Cutera Qswitch Laser System
by Cutera, Inc.
510(k) K102954
Cutera Qswitch Laser System is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Cutera, Inc., cleared under FDA 510(k) K102954 on 22 Jun 2011, 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 | NumberK102954 | Date22 Jun 2011 | StatusActive |
Official records
- FDA 510(k) database K102954
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- Withdrawn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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