Dermablate Effect
by Asclepion Laser Technologies GmbH
510(k) K081541
Dermablate Effect is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Asclepion Laser Technologies GmbH, cleared under FDA 510(k) K081541 on 23 Feb 2009, 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 | NumberK081541 | Date23 Feb 2009 | StatusActive |
Official records
- FDA 510(k) database K081541
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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