510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050397Substantially Equivalent

Velasmooth, Shaper

Syneron Medical, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050397 is the FDA 510(k) clearance record for VELASMOOTH, SHAPER, a class II device, cleared for Syneron Medical, Ltd. on under FDA product code NUV (Massager, Vacuum, Light Induced Heating). FDA's definition for product code NUV reads: "The device is intended to temporarily alter the appearance of cellulite". FDA records list 35 510(k) clearances for Syneron Medical, Ltd., from to . As of , FDA records show no recalls naming K050397.

Clearance record

Decision date
Received
(113 days to decision)
Product code
NUV Massager, Vacuum, Light Induced Heating
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Syneron Medical, Ltd. 601 Pennsylvania Ave., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NUV

Trailing 12 months
1 clearance under product code NUV in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NUV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260