Skip to content

Dermablate M18-4300-000

by Asclepion Laser Technologies GmbH

Dermablate M18-4300-000 is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Asclepion Laser Technologies GmbH, cleared under FDA 510(k) K241600 on 3 Jul 2024 and listed in FDA GUDID since 11 Nov 2024 (UDI-DI 04058784002624), 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) K241600

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 Number04058784002624 UDI-DI Date11 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK241600 Date3 Jul 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241600 decided 3 Jul 2024 Active
  • FDA GUDID UDI-DI 04058784002624 listed 11 Nov 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241600
  2. Listed FDA GUDID 04058784002624

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dermablate
Generic name
Multi-modality skin surface treatment system generator
Model / reference
M18-4300-000
Primary DI / UDI-DI
04058784002624
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

Cleared under the same submission (K241600)

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)