Syneron Medical, Ltd.: FDA filings under this applicant name

FDA lists 35 510(k) clearances under the applicant name “Syneron Medical, Ltd.” (first 2002, latest 2017), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 99 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Syneron Medical, Ltd. took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.

Top product codes

Review panels

• General and Plastic Surgery (35)

Most recent Syneron Medical, Ltd. 510(k) clearances

25 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Syneron Medical, Ltd..

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Syneron Medical, Ltd. is the lead sponsor of 18 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT03430245: VelaShape III & UltraShape Power for Thigh Circumference Reduction (Completed, started 2018-02-19)
• NCT03078647: Profound Dermal and SubQ Cartridges for the Treatment of Cellulite (Completed, started 2017-09-13)
• NCT02999763: SlimShape Device for Abdominal Fat and Circumference Reduction (Completed, started 2017-01-13)
• NCT02748928: UltraShape Power for Abdominal Fat and Circumference Reduction (Completed, started 2016-06-08)
• NCT02700204: Histological Study to Evaluate Skin Changes After PicoWay® 1064 nm and 532nm Picosecond Fractional Laser Treatment (Completed, started 2015-09)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Syneron Candela Corporation (5 510(k)s)
• Syneron Beauty , Ltd. (4 510(k)s)
• Syneron, Ltd. (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Syneron Medical, Ltd.?

FDA lists 35 510(k) clearances under the applicant name “Syneron Medical, Ltd.” (first 2002, latest 2017), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Syneron Medical, Ltd.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Syneron Medical, Ltd. is 99 days.

Which FDA product codes appear under Syneron Medical, Ltd.?

The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 20); OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption, 6); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4).

Next steps

• See all 35 Syneron Medical, Ltd. clearances with predicates and recalls
• Run predicate analysis for product code GEX, Syneron Medical, Ltd.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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