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MCL 31 Dermablate 1821

by Asclepion Laser Technologies GmbH

MCL 31 Dermablate 1821 is a Class II device made by Asclepion Laser Technologies GmbH, cleared under FDA 510(k) K150140 on 5 Jun 2015 and listed in FDA GUDID since 14 Nov 2016 (UDI-DI 04058784000088), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K150140

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04058784000088 UDI-DI Date14 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150140 Date5 Jun 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150140 decided 5 Jun 2015 Active
  • FDA GUDID UDI-DI 04058784000088 listed 14 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150140
  2. Listed FDA GUDID 04058784000088

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MCL 31 Dermablate
Generic name
Multi-modality skin surface treatment system generator
Model / reference
1821
Primary DI / UDI-DI
04058784000088
510(k) Number
FDA product code
GEX
GMDN term
Multi-modality skin surface treatment system generator
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multi-modality skin surface treatment system generator

Other devices from Asclepion Laser Technologies GmbH

See all devices from Asclepion Laser Technologies GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)