Manufacturer
El.En S.P.A.MOTUS PRO Family
Country / Region:Italy (IT)Submission type:Special
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
- K241459
- Device name
- MOTUS PRO Family
- Company
- El.En S.P.A.
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-05-23
- Decision date
- 2024-06-21
- Submission type
- Special
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalPigment treatmentVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
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).
Intended Use
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).
Device Description
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
Predicate devices
2DEKA Motus AZ
DEKA AGAIN PRO family
K241459 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K241459 as a predicate
