Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime on all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime on all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
MOTUS PRO family is a medical laser family equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. The device available with Alexandrite source only has the brand name MOTUS PRO AX. The modifications to the device respect to DEKA Motus AZ (K211821) consist of a restyling of the device (chassis, cover plastic and GUI) and on modification to spot size ranges (new spot size available), pulse duration, 755nm maximum fluence and maximum pulse repetition rate. The modified specifications are within the range of the already cleared reference device (K233090). The intended use of modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since clearance of.
Summary parsed at:2026-06-01 05:28:22 UTC
