510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160896Substantially Equivalent

Ultrashape Power System

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

K160896 is the FDA 510(k) clearance record for ULTRASHAPE POWER SYSTEM, a class II device, cleared for Syneron Medical, Ltd. on under FDA product code OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption). FDA's definition for product code OHV reads: "A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for...". FDA records list 35 510(k) clearances for Syneron Medical, Ltd., from to . As of , FDA records show no recalls naming K160896.

Clearance record

Decision date
Received
(99 days to decision)
Product code
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Regulation
21 CFR 878.4590
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Syneron Medical, Ltd. Tavor Bldg., Industrial Zone, P.O.B. 550, Yokneam Illit, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OHV

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