CAPRI

The CAPRI is a diode laser surgical instrument operating at 1450 nm wavelength, indicated for dermatological use including incision, excision, ablation, and vaporization of soft tissue with hemostasis. It is also used to treat various skin conditions including acne, acne scars, facial wrinkles, and sebaceous hyperplasia. Laser energy is delivered through an optical fiber attached to a handpiece with an integrated laser guide tip for aiming and focusing.

CAPRI uses a diode laser at 1450 nm with a 6 mm spot size (±10%), laser output of 4–12 J/cm², pulse duration of 210 ms (52.5 ms × 4), 1 Hz repetition rate, and cryogen gas spray cooling (20–38 ms). The predicate device (Candela Smoothbeam) shares the same wavelength, pulse duration, and repetition rate but offers variable spot sizes (4 and 6 mm) and slightly higher output range (4–25 J/cm² depending on spot size) with longer cooling duration (20–85 ms).

Testing compliance with IEC 60601-1:2005/AMD1:2012/AMD2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-2-22:2019, IEC 60825-1:2014, ISO 10993-1 for biocompatibility, and FDA guidance on software verification and validation for medical device software.

CAPRI is substantially equivalent because it has identical indications for use as the predicate device (Candela Smoothbeam K041242), incorporates the same basic diode laser technology and operating wavelength, and non-clinical verification/validation testing demonstrates it is as safe and effective as the predicate with no new safety or effectiveness issues introduced.