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Diolaze AS602143A

by Inmode MD, Ltd.

Diolaze AS602143A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K123682 on 27 Feb 2013 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 07290016633139), 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) K123682

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 Number07290016633139 UDI-DI Date25 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123682 Date27 Feb 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123682 decided 27 Feb 2013 Active
  • FDA GUDID UDI-DI 07290016633139 listed 25 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123682
  2. Listed FDA GUDID 07290016633139

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Diolaze
Generic name
Dermatological diode laser system
Model / Ref / Catalog
AS602143A
Primary DI / UDI-DI
07290016633139
510(k) Number
FDA product code
GEX
GMDN term
Dermatological diode laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

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Properties

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