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Hybrid Cooling Set

by Lutronic Corporation

Hybrid Cooling Set is a Class II device made by Lutronic Corporation, listed in FDA GUDID since 9 Sep 2016 (UDI-DI 08809447651453), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809447651453 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Dermatological solid-state laser system
Model / reference
Hybrid Cooling Set
Primary DI / UDI-DI
08809447651453
FDA product code
GEX
GMDN term
Dermatological solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dermatological solid-state laser system

Similar devices in this category

Other devices filed under Dermatological solid-state laser system.

Other devices from Lutronic Corporation

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Properties

  • Prescription use
Other properties (14, all answered No)