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LP560

by Cutera, Inc.

LP560 is a Class II device made by Cutera, Inc., cleared under FDA 510(k) K050047 on 31 Mar 2005 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816722022165), active as of 21 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 21 Oct 2026

Documents

510(k) K050047

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816722022165 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050047 Date31 Mar 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050047 decided 31 Mar 2005 Active
  • FDA GUDID UDI-DI 00816722022165 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050047
  2. Listed FDA GUDID 00816722022165

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Dermatological laser beam guiding handpiece
Model / reference
LP560
Primary DI / UDI-DI
00816722022165
510(k) Number
FDA product code
GEX
GMDN term
Dermatological laser beam guiding handpiece
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Dermatological laser beam guiding handpiece.

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Properties

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