What is Re2O?
Like AlloDerm, ground into powder and injected into the face.
Is it approved in Korea?
Not as a drug or device. Korea treats it as human tissue.
Is it banned in Southeast Asia?
Thailand approved it in its strictest class. Indonesia hasn’t registered it.
In 2025, more than one in five donor-skin tissue products sent to Korean medical facilities went into a single beauty injection: Re2O [1].
Short answer:
- In Korea, Re2O is neither a drug nor a medical device. It is donor skin with the cells removed, ground into powder (human acellular dermal matrix). Korean law calls it human tissue, so it skips the product trials and approval that fillers need [2][3].
- “Southeast Asia calls it dangerous” is only half right. Korean press, citing the company, reports that Thailand licensed it as a Class 4 medical device, its strictest class [4]. Indonesia’s drug agency says it is not approved, not registered and not sold there [5].
- The face evidence is one trial: 20 people, 20 weeks [6]. No serious adverse events, but too small to catch rare problems.
Why can Korean clinics use it without product approval?
The law calls donor skin human tissue [2], a category built for burn and reconstruction surgery. So Korea’s drug regulator (MFDS) checks the tissue bank and the donor’s infection tests, not whether the tissue works or is safe when injected into a face [7].
Hyaluronic acid (HA) fillers and PN skin boosters, injected in the same places, are Class 4 medical devices that need trials and approval [8].
At the National Assembly audit on 7 October 2026, Korea’s health minister said (my translation) the Human Tissue Act “has limits” here and “there is a gap”. The MFDS is studying whether to manage these products as medical devices [10]. An advertising ban and a duty to tell patients the source and get signed consent are also being discussed [1].
How do Southeast Asian countries handle it?
- Thailand: Re2O and Re2O Fine got Class 4 (highest) device licences in September 2026, per Korean press citing the company. The company says Thailand has no separate tissue law, so it was reviewed as a device; the product did not change [4]. I could not find the Thai FDA record itself.
- Indonesia: BPOM’s head said it “has not been approved, is not registered and is not circulating in Indonesia.” Under BPOM Regulation No. 25 of 2025, anything from human cells or tissue is not allowed in cosmetics; as a drug it would need review and registration, and BPOM said it would act on illegal sales [5].
- Elsewhere: Korean press says it entered Singapore and Myanmar as a skin tissue injection [11]; I could not confirm this with their regulators. For Vietnam, Malaysia and the Philippines, where the company plans to expand [4], I found no regulator statement.
Why do the rules differ by country?
Human tissue can carry human disease. In 2021 in the US, a bone graft from one donor went into 113 people; 87 showed signs of tuberculosis [12]. That product held live cells, unlike Re2O, but it is why regulators look first at donor screening and tracing each donor’s tissue to each patient [13].
The second reason is purpose. Korea’s law covers tissue for “restoring health or preventing disability” [2]. Does a beauty injection fit that, or is it a product to review? Korea chose the first answer, Thailand the second.
How much evidence is there?
- Re2O face trial: 20 people, split-face, double-blind, one session, 20 weeks [6]. It compared “HA + matrix” with HA alone. No serious adverse events.
- Another maker’s powder plus PRP: 16 people with acne scars, 3 months [14].
- I found no study counting how often lumps or infections happen. Not “never”, just not yet counted.
What I tell my patients before this skin booster
It is a new material, not a long-tested standard. That is my clinical judgement about the evidence, not a proven fact. Ask three things first:
- Will you record the product name and lot number? If a problem shows up, the lot is the first clue.
- Will you tell me it comes from donated tissue and ask for my consent? Korea is working to make this a duty [1].
- If something goes wrong at home, will my own doctor know this product? Where it is not registered, like Indonesia, that may be hard.
More: Re2O vs Rejuran vs Juvelook, human tissue-derived skin boosters in Korea, and how to find a non-factory clinic in Korea, where these questions are welcome.
Have a question about a skin booster? Ask me on LINE or by email — details on the Contact page.
FAQ
Is Re2O FDA approved in the US?
I could not confirm a US product approval. The company mentions an FDA “listing” [9]; I could not confirm that this means approval. US rules let tissue skip separate approval only if it meets every condition, such as “minimal manipulation” and doing the same job in the patient as in the donor [15]. Korean press says it is unclear whether powdered skin injected into the face fits [11].
Is Re2O made from cadaver skin?
It is made from skin donated after death. The cells are removed and the protein framework left behind, such as collagen, is ground into powder [3][4]. The company says it uses only US tissue banks and donors who agreed to cosmetic use, with eight infection tests plus virus inactivation and sterilisation [9].
Does Thailand’s Class 4 mean Re2O is dangerous?
No. Class 4 is the class Thailand reviews most strictly, and the licence is needed before sale [4]. How strictly a product is reviewed and whether it is safe are different questions.
References
- Park MJ. [Exclusive] Beauty injection made from donated bodies: government reviews applying “distribution priority” to imported tissue. Money Today, 22 Sep 2026 (in Korean). mt.co.kr
- Act on Safety and Management of Human Tissue, Article 3 (definitions) and Article 12 (distribution). Korean Law Information Center (in Korean). law.go.kr
- L&C Bio. Re2O product page (category “human tissue”) (in Korean). lncbio.co.kr; Hans Biomed. CellREDM product page (in Korean). hansbiomed.com
- L&C Bio’s Re2O receives Thai medical device approval. Newspim, 16 Sep 2026 (in Korean). newspim.com; Dealsite, 16 Sep 2026 (in Korean). dealsite.co.kr
- Skin booster belum ada di RI, dilarang digunakan dalam kosmetika. Bloomberg Technoz, 19 Sep 2026 (in Indonesian). bloombergtechnoz.com
- Lee YI, Chau NH, Nguyen NH, et al. Injectable particulated human acellular dermal matrix booster for skin restoration. Int J Mol Sci 2026;27(5):2193. 10.3390/ijms27052193 (PMID 41828422; NCT07155278)
- ECM tissue grafts classified as “human tissue”: a regulatory blind spot. Newsis, 28 Jul 2026 (in Korean). newsis.com
- Moon SH. ECM consortium launched: skin boosters face a test of “setting standards”. Medical Times, 18 Sep 2026 (in Korean). medicaltimes.com
- “Not a cadaver skin injection”: L&C Bio rebuts Re2O safety and regulation controversy. Newspim, 29 Apr 2026 (in Korean). newspim.com
- Lee SH. Minister Jeong Eun-kyeong: “a management gap for ECM skin boosters”. MTN, 7 Oct 2026 (in Korean). mtn.co.kr
- Park JH. ECM skin boosters’ overseas expansion “in a fog” as domestic regulation nears. MTN, 8 Oct 2026 (in Korean). mtn.co.kr
- Schwartz NG, Hernandez-Romieu AC, Annambhotla P, et al. Nationwide tuberculosis outbreak in the USA linked to a bone graft product: an outbreak report. Lancet Infect Dis 2022;22(11):1617-1625. 10.1016/S1473-3099(22)00425-X00425-X) (PMID 35934016)
- Solves P, Mirabet V, Alvarez M. Hepatitis B transmission by cell and tissue allografts: how safe is safe enough? World J Gastroenterol 2014;20(23):7434-7441. 10.3748/wjg.v20.i23.7434 (PMID 24966613)
- Park S, Huang L, Ao X, et al. Micronized acellular dermal matrix combined with platelet rich plasma in the treatment of atrophic acne scars: a self-controlled split face study. J Cosmet Dermatol 2024;23(7):2386-2391. 10.1111/jocd.16293 (PMID 38558364)
- US Code of Federal Regulations, 21 CFR 1271.10. Cornell Legal Information Institute. law.cornell.edu
Disclaimer: This is general information, not a diagnosis or a treatment plan. Brand names are discussed for information only and are not endorsements. Injections and prescription medicines should be chosen and given only by a licensed professional who has examined you, and what suits another person may not suit you.
14 years in practice · replies to messages herselfA doctor in Korea, in practice since 2012 — your K-Beauty Doc. Physician in non-surgical aesthetic medicine, practising in Ansan, South Korea. Every article here is written from clinical practice and the published literature. Not medical advice.
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