510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123407Substantially Equivalent

Cellulaze Laser

Cynosure, LLC, Wesford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K123407 is the FDA 510(k) clearance record for CELLULAZE LASER, a class II device, cleared for Cynosure, Inc. on under FDA product code OYW (Laser, Cellulite Appearance). FDA's definition for product code OYW reads: "For the removal of fat through laser lipolysis". FDA records list 107 510(k) clearances for Cynosure, Inc., from to . As of , FDA records show no recalls naming K123407.

Clearance record

Decision date
Received
(144 days to decision)
Product code
OYW Laser, Cellulite Appearance
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cynosure, Inc. 5 Carlisle Rd., Wesford MA
510(k) summary
Statement
Third party review
No

Clearances, product code OYW

Trailing 12 months

FDA records hold no clearances under product code OYW in the trailing twelve months.

FDA records show no clearances under product code OYW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OYW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260