Is EBO2 (EBOO) FDA Approved? What the FDA Has Said and How to Check a Claim

EBO2 (also called EBOO) is not FDA-approved, and neither is any other form of ozone therapy [1][2]. This guide sets out what the FDA itself has written about ozone and about EBOO equipment, what the words “approved”, “cleared”, and “registered” mean when a clinic uses them, and how to check any FDA claim in the agency’s own databases, with what each result would and would not tell you. A description of the procedure itself is in our pillar guide on what EBO2 is.

The short answer

No FDA approval exists for ozone therapy for any condition [1]. The FDA’s device rule on ozone opens with the sentence “Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy” [1]. In July 2025 the FDA told the maker of two devices sold for EBOO and ultraviolet blood irradiation that both were adulterated and misbranded because neither had premarket approval or clearance [2]. A registration number is not approval either: a federal regulation says that registering a device establishment “does not in any way denote approval of the establishment or its products” [3], and another says the same of a 510(k) clearance [4]. The FDA also does not approve health care providers, so no clinic is FDA-approved as a clinic [5].

What the FDA’s ozone rule says

The rule is 21 CFR 801.415, part of the FDA’s device labeling regulations, which the eCFR dates to a Federal Register notice of February 13, 1976 [1]. Its first paragraph calls ozone a toxic gas with no known useful medical application, and adds that to work as a germicide ozone “must be present in a concentration far greater than that which can be safely tolerated by man and animals” [1]. The second paragraph describes irritation of the mucous membranes and lungs and warns that pulmonary edema from inhaled ozone “is usually delayed for some hours after exposure”, so that neither symptoms nor smell is a reliable warning [1].

The third paragraph bears on medical use: any device that generates ozone “will be considered adulterated and/or misbranded” if it is used or intended for use under any of five conditions, and one of them is use “in any medical condition for which there is no proof of safety and effectiveness” [1]. The section’s numbers, 0.05 parts per million for indoor air and a 0.10 parts per million industrial threshold that it attributes to the American Conference of Governmental Industrial Hygienists, concern air that people breathe, and the rule sets no dose for ozone in blood [1].

What the FDA said about EBOO devices in July 2025

On July 7, 2025, the FDA’s Center for Biologics Evaluation and Research sent a warning letter to O3UV, LLC of Grand Ledge, Michigan, after inspecting the firm from August 23 to August 31, 2023 [2]. The letter covers two products, Champion Full Spectrum and EBOO Full Spectrum UV, which it says are meant to expose a patient’s blood to ozone and ultraviolet light before the blood is returned intravenously, during UV blood irradiation or EBOO [2]. According to the letter, the products were intended for diseases including autoimmune, cardiovascular, and respiratory conditions and were distributed to physicians, nurses, and other practitioners across the United States [2].

The letter asked for a written answer within 15 working days and said that failing to address the matters “may result in legal action being initiated by FDA without further notice”, such as seizure or an injunction [2]. When we checked the FDA’s warning letter list on October 2, 2026, the row for this letter showed no response letter and no close-out letter [6]. The FDA notes on that list that matters in a warning letter may have been the subject of later interaction with the recipient “that may have changed the regulatory status of issues discussed in the letter” [6]. It issues a close-out letter only after it has verified the corrections, usually by a follow-up inspection [7].

A warning letter is the FDA’s notice of what it believes are significant violations, and it gives the recipient a chance to respond or to disagree [7]. This one concerns one manufacturer and two products. It does not name or describe any clinic [2].

What “approved”, “cleared”, and “registered” mean

The FDA places dialysis equipment among the moderate-risk devices that reach the market through 510(k) clearance [5]. The filters in the EBOO kits the FDA inspected were hemodialyzers [2], and the classification rule for high-permeability hemodialysis systems describes such filters as intended “for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions” [12]. A cleared filter is therefore cleared for the uses written in its 510(k) [9]. Our guide to EBOO devices and FDA status applies this to each part of the circuit, and our comparison of EBOO and dialysis covers the filter itself.

How clinics word FDA status

Of the 177 clinics in our directory, we could read the EBO2 page of 174 as of October 4, 2026. Of those 174, 148 do not say whether EBO2 or its equipment is FDA-approved, 23 say EBO2 or ozone therapy is not FDA-approved, 3 use an FDA term for their equipment, and none says the treatment itself is FDA-cleared or approved. The three equipment statements between them use the words registered, cleared, and approved, which the table above shows are different things. We publish this wording only as totals, never clinic by clinic. The “From our data” section at the end of this guide recomputes the figures each time the site is built, and the clinic transparency report shows what else clinics state. Our guide on how to read a clinic’s EBO2 page takes this wording phrase by phrase.

How to check an FDA claim yourself

1. Write down the claim exactly. Note what it attaches to: the treatment, a device, the ozone, or the clinic. If a device is named, ask the clinic in writing for the manufacturer, the brand and model, and any FDA number it relies on. A 510(k) number looks like K043207 [13].
2. Search Devices@FDA (accessdata.fda.gov/scripts/cdrh/devicesatfda) by device name and then by company name. The FDA describes it as a catalog of cleared and approved devices that searches both the 510(k) and the PMA databases [10][14].
3. Search the three marketing databases directly if you have a number or want more control: the 510(k) database, searchable by 510(k) number, applicant, device name, or product code; the PMA database; and the De Novo database, all at accessdata.fda.gov [14][15]. Try one distinctive word of a brand name at a time, because the same word often belongs to unrelated products.
4. Read what the record covers. A 510(k) decision letter finds the device substantially equivalent “for the indications for use stated in the enclosure”, and the Indications for Use page in the PDF is where the cleared uses are written [13]. Compare those uses with what the clinic says the device does. The FDA’s 510(k) page says a new 510(k) is required when a device is to be marketed for a new or different intended use [9].
5. Search Registration and Listing by company or device name. If a listed device needs premarket authorization, the owner is expected to give the FDA its 510(k), De Novo, or PMA number, so a listing that shows one points to the record to read [14][11].
6. Search the warning letter list on fda.gov for the company and the product names, and check the response and close-out columns for any letter found [6]. An empty result here is weak evidence, for the reasons below.
7. For a claim about ozone as a drug, search Drugs@FDA, which covers most drug products approved since 1939 [16]. A National Drug Code listing is not an approval: the FDA describes that directory as one of “approved and unapproved finished drugs” [5].
8. For a claim about safety, the MAUDE adverse event database and the device recall database hold reports and recalls [14]. The FDA warns that a report “does not necessarily demonstrate that the device caused or contributed to the adverse outcome or event”, and that these reports cannot show how often events happen [17]. Our guide to ozone therapy adverse events sets out a MAUDE search for ozone reports.

Two of our own test searches, run on October 2, 2026, show why an empty or noisy result settles nothing. A search of the warning letter list for “Connealy”, part of the name of the Irvine, California clinic that received a joint FDA and FTC letter in May 2020, returned no results, although that letter is still on the FDA’s website [6][18]. A search for “EBOO” returned the 2025 O3UV letter and also a 2021 letter about apricot-seed products whose text contains the word “eBook” [6].

What our own searches found

We ran these checks for EBOO and ozone terms on October 2, 2026. The 510(k), PMA, and registration search forms answered our automated requests with either a blank form or an automated check, which we did not try to get around, so we searched those three databases, and the FDA’s unique device identifier and classification data, through openFDA, a public data service that is an initiative of the FDA’s Office of Health Informatics [19][20]. The De Novo database, the AccessGUDID device identifier search, and the warning letter list answered our searches directly [15][14][6].

• “EBOO” and “EBO2” returned no 510(k), PMA, De Novo, registration and listing, or unique device identifier record [20][15].
• “Ozone” in a 510(k) device name returned 11 records: six sterilizers or sterilization wraps and indicators, four systems that disinfect the water or solution systems used for dialysis, and one test strip for detecting ozone in water used for hemodialysis [20][21]. The only one named simply “Ozone Generator”, K043207, cleared on November 4, 2005, is an accessory for disinfecting a dialysis solution mixing and distribution system, which is then rinsed “until the system is residual free of ozone” [13]. None of the 11 is for exposing a patient or a patient’s blood to ozone.
• The FDA’s device classification data had no device type with “ozone” in its name or its definition [19].
• Drugs@FDA had no application with ozone as an active ingredient, while the same search for oxygen returned 20 applications [16].
• The warning letter list returned seven letters for “ozone”: the O3UV letter, three about devices sold to clean CPAP equipment with ozone, two about products marketed as drugs, and one about a manufacturer’s own ozone sanitizing step [6]. Only the O3UV letter concerns equipment for treating blood.

Our guide to EBOO devices and FDA status gives the results for each device name that clinics in our data use.

Who oversees ozone therapy if the FDA has not approved it

The FDA regulates products, and it says it does not approve health care providers, including physician offices [5]. Its ozone rule is written about devices used or intended for use in medical conditions without proof of safety and effectiveness [1], and its 2025 action on EBOO equipment was addressed to a manufacturer [2]. Federal prosecutors have also charged a physician over ozone devices: in June 2025 a Richmond, Virginia pain physician was indicted on counts that include receiving adulterated and misbranded devices, and the indictment alleges that he used three FDA-unapproved devices that produced medical ozone gas and billed ozone injections as nerve blocks [22]. The Justice Department’s release notes that charges are only allegations [22].

State medical boards license physicians and act on how they practice, and their records on ozone differ:

• Alabama, 2011. Asked by a physician for permission to use ozone, the state Board of Medical Examiners said it does not regulate specific practice procedures and declined to make a recommendation. It added that, “due to the experimental and investigational nature of the non-FDA approved therapy, the Board would be extremely concerned should any patient complaints be received related to the use of Ozone therapy” [23].
• California, 2024. The Medical Board placed a physician on five years’ probation, during which he “is prohibited from performing intravenous ozone therapy treatment”. The accusation behind the case says a patient lost consciousness during an intravenous ozone treatment in December 2020 and was later diagnosed with an air embolism and a stroke [24].

None of these is an approval of ozone therapy, and none speaks for other states. We have not surveyed every state’s rules, and nothing in this guide is a legal opinion on whether a given clinic’s practice is lawful.

What federal agencies have done about ozone claims

Each of these actions concerned specific products or specific claims. None of them is a general ruling on ozone therapy as a practice.

Outside the United States

None of the regulatory documents we hold from other countries approves EBOO. Brazil’s 2023 law allows ozone therapy only as a complementary procedure, performed by a university-level health professional registered with a professional council and with an ozone generator regularized by the national health regulator [30]. In 2005 Italy’s Health Ministry relayed its Superior Health Council’s view that no controlled clinical studies were available to support the efficacy of oxygen-ozone therapy and that it can cause serious and potentially fatal side effects [31]. Our guide to what regulators abroad have said compares those documents country by country, including Germany’s exclusion of ozone therapy from statutory health insurance, and our regulatory tracker lists every record we hold with its exact language.

What we could not verify

• The full database search forms. The FDA’s 510(k), PMA, and Registration and Listing search pages return a blank form to plain requests and show an automated check to a form submission, which we did not try to pass. We used openFDA’s copies of those databases instead; openFDA updates its 510(k) data monthly and says not to rely on it for decisions about medical care [20]. A reader’s own search on the FDA’s pages may show records added since.
• Absence. A search can show that a record exists. It cannot show that none exists under another name, a parent company, a distributor, or a model number.
• The O3UV letter’s outcome. We do not know whether the firm answered the FDA or changed its products after July 2025. The FDA’s list showed no response or close-out letter on October 2, 2026 [6].
• The procedure as practiced. No FDA document we found addresses EBOO as performed in clinics. The agency’s statements we found concern ozone devices and named products [1][2].
• Clinics’ equipment. As of October 4, 2026, 21 of the 174 clinics whose page we could read named a device or system, and a brand name on a web page does not identify a maker or model, so we cannot match any clinic’s machine to an FDA record.
• State law. We have not surveyed the rules of all 50 states on ozone therapy.
• Earlier claims about other countries. An earlier version of this guide summarized ozone therapy rules in Germany, Spain, several Italian regions, and Cuba, drawing on practitioner associations and a Cuban newspaper. Our sourcing rules now allow direct reading only of public institutions’ own documents. Our guide to regulators abroad now covers Germany and Italy from the regulators’ own documents; we hold no primary documents for Spain or Cuba, so we make no claim about them.

How this guide was made

This guide rests on 32 sources, nearly all of them the FDA’s, the FTC’s, the Justice Department’s, and state boards’ own documents and databases, each read for this update. The counts of how clinics word FDA status come from our clinic dataset as read between September 28, 2026 and October 4, 2026 (174 readable pages among 177 listed clinics). The database results come from searches we ran on October 2, 2026, and we keep the queries and results on file. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.