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Handpiece LP Nd:Yag 1064 Cooled for Harmony XL Pro (color cooled gray)

by Alma Lasers Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290110123772 UDI-DI Date2 Mar 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Generic Name
Multi-modality skin surface treatment system
Model / Ref / Catalog
1, AAHP08031501
Primary DI / UDI-DI
07290110123772
510(k) Number
FDA Product Code
GEX
GMDN Term
Multi-modality skin surface treatment system
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K072564)

Show all (12)

Other devices from Alma Lasers Ltd.

See all devices from Alma Lasers Ltd. →

Properties

  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No