Profile Multi-Platform System
510(k) K060033
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) K060033 on 28 Feb 2006, 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 | NumberK060033 | Date28 Feb 2006 | StatusActive |
Official records
- FDA 510(k) database K060033
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- Withdrawn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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