Device details
FDA 510(k) registration fields
- K number
- K160488
- Device name
- Cutera enlighten III Laser System
- Company
- Cutera, Inc.
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-02-22
- Decision date
- 2016-10-28
- Submission type
- Traditional
- Technology type
- Q-Switched(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
