510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171992Substantially Equivalent

SculpSure

Cynosure, LLC, Wesford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171992 is the FDA 510(k) clearance record for SculpSure, a class II device, cleared for Cynosure, Inc. on under FDA product code PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use). FDA's definition for product code PKT reads: "Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas". FDA records list 107 510(k) clearances for Cynosure, Inc., from to . As of , FDA records show no recalls naming K171992.

Clearance record

Decision date
Received
(85 days to decision)
Product code
PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Regulation
21 CFR 878.5400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cynosure, Inc. 5 Carlisle Rd., Wesford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PKT

Trailing 12 months

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

FDA records show no clearances under product code PKT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PKT, 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