Manufacturer
Cutera, Inc.AviClear Laser System
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251149
- Device name
- AviClear 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
- 2025-04-14
- Decision date
- 2025-07-11
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Acne treatment
- Primary application
- Acne treatment
- Classification source
- AI classified
Indications for Use
The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
Intended Use
The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
Device Description
The AviClear Laser System has a new Large handpiece with a 3 mm x 3 mm square spot and rectangular arrays of up to 25 spots; and the post-treatment skin cooling duration was reduced from 2 seconds to 1 second. The differences in technological characteristics do not raise different questions of safety and effectiveness, as demonstrated in the clinical study.
Summary parsed at:2026-06-01 05:22:58 UTC
Predicate devices
1AviClear Laser System
K251149 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251149 as a predicate