DEKA MOTUS AX

El.En Electronic Engineering Spa

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

2

Device details

FDA 510(k) registration fields

K number
K162886
Device name
DEKA MOTUS AX
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-10-17
Decision date
2017-06-19
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The DEKA Motus AX laser system is indicated for:

- 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.
- Treatment of wrinkles.
- Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Intended Use

The DEKA Motus AX laser system is indicated for: 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. Treatment of wrinkles. Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Device Description

The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers 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. Handpiece activation is either by footswitch or fingerswitch.

Summary parsed at:2026-06-01 05:59:09 UTC

Predicate devices

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K162886 references 1 predicate/reference device

Cited as predicate

2

2 submissions cite K162886 as a predicate