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MOSAIC 3D Sapphire Tip Package

by Cynosure Lutronic Technology Corporation

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800291821085 UDI-DI Date15 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Mosaic 3D
Generic Name
Dermatological solid-state laser system
Model / Reference
Sapphire Tip Package
Description
8800291820934 S20 Tip 2ea, 8800291820965 S10 Tip 2ea
Primary DI / UDI-DI
08800291821085
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

Other devices from Cynosure Lutronic Technology Corporation

See all devices from Cynosure Lutronic Technology Corporation →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

  • 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
  • Serial Number: No
  • Expiration Date: No