Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
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
AviClear Laser System
K251149 references 1 predicate/reference device
No later 510(k)s cite this device yet
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