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Deka Synchro Repla:y Family of Laser Systems

by El.En Electronic Engineering Spa

510(k) K150516

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK150516 Date13 Apr 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DEKA SYNCHRO REPLA:Y family of laser systems is a device designed for temporary and permanent hair reduction. It operates by selectively targeting melanin in hair follicles to achieve stable long-term or permanent hair reduction.

The device is supplied as a laser system and is intended for use in cosmetic procedures. It is regulated under FDA 510(k) clearance and is not indicated for clinical use. The device is not reusable and must be used in accordance with the manufacturer's instructions.

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Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DEKA SYNCHRO REPLA:Y laser system used for?

    The DEKA SYNCHRO REPLA:Y family of laser systems is designed for temporary and permanent hair reduction by selectively targeting melanin in hair follicles to achieve stable long-term results.

  • Is the DEKA SYNCHRO REPLA:Y laser system reusable?

    No, the DEKA SYNCHRO REPLA:Y laser system is not reusable and must be used in accordance with the manufacturer's instructions to ensure proper function and safety.

  • What regulatory status does the DEKA SYNCHRO REPLA:Y laser system have?

    The DEKA SYNCHRO REPLA:Y laser system is regulated under FDA 510(k) clearance with decision code SESE and is intended for cosmetic procedures, not clinical use.

  • How is the DEKA SYNCHRO REPLA:Y laser system supplied?

    The device is supplied as a complete laser system and is intended for use in cosmetic procedures, with specific instructions provided by the manufacturer for proper operation.