Profile Multi-Platform System
510(k) K081352
Profile Multi-Platform System is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Sciton, Inc, cleared under FDA 510(k) K081352 on 23 Oct 2008, 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 | NumberK081352 | Date23 Oct 2008 | StatusActive |
Official records
- FDA 510(k) database K081352
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- Withdrawn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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