Dermalux Flex MD
by Aesthetic Technology, Ltd. 2 variants
510(k) K212275
Dermalux Flex MD is a Class II device made by Aesthetic Technology, Ltd., cleared under FDA 510(k) K212275 on 18 Nov 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212275 | Date18 Nov 2021 | StatusActive |
Official records
- FDA 510(k) database K212275
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OHS
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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