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MaxY Handpiece 2520B-Y026

by Cynosure, LLC

MaxY Handpiece 2520B-Y026 is a Class II device made by Cynosure, LLC, cleared under FDA 510(k) K110907 on 22 Jun 2011 and listed in FDA GUDID since 24 Jul 2017 (UDI-DI 00841494106843), active as of 22 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 22 Oct 2026

Documents

510(k) K110907

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841494106843 UDI-DI Date24 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK110907 Date22 Jun 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110907 decided 22 Jun 2011 Active
  • FDA GUDID UDI-DI 00841494106843 listed 24 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110907
  2. Listed FDA GUDID 00841494106843

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MaxY Handpiece
Generic name
Multi-modality skin surface treatment system
Model / reference
2520B-Y026
Primary DI / UDI-DI
00841494106843
510(k) Number
FDA product code
ONG, 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

Category: Multi-modality skin surface treatment system

Cleared under the same submission (K110907)

and 8 more cleared under K110907

Other devices from Cynosure, LLC

See all devices from Cynosure, LLC →

Properties

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