Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
CAPRI is indicated for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne, Treatment of atrophic acne scars, Treatment of facial wrinkles, Treatment of mild to moderate acne vulgaris, Treatment of Sebaceous Hyperplasia.
CAPRI is indicated for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne, Treatment of atrophic acne scars, Treatment of facial wrinkles, Treatment of mild to moderate acne vulgaris, Treatment of Sebaceous Hyperplasia.
CAPRI is a diode laser which delivers energy at a wavelength of 1450 nm. Laser energy is delivered through an optical fiber that is attached to the handpiece. Laser guide tip is attached to the handpiece ensures that the spot is focused on the skin and serves as the laser beam aiming device. CAPRI consists of the following components: Main Unit, Accessories: Handpiece & Laser Guide Tip, Foot Switch, Remote Interlock Connector, Gas Spray (HFC-134), Key Switch, Eye Protection Goggle.
Summary parsed at:2026-06-01 05:19:05 UTC
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K254271 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K254271 as a predicate
