AviClear Laser System
FDA 510(k) clearance K251149 · decided 2025-07-11
Clearance details
- K-number
- K251149
- Device name
- AviClear Laser System
- Applicant
- Cutera, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-14
- Decision date
- 2025-07-11
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Brisbane, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cutera
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.