Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Syneron Medical and its 3 subsidiaries with 135 510(k) clearances and 5 device recalls. The most recent is a 510(k) clearance dated Jul 1, 2024: Profound Matrix.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Syneron Medical and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 1, 2024 | Profound MatrixK240070 · GEI | 510(k) clearances |
| Jun 1, 2023 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)K230990 · GEX | 510(k) clearances |
| Oct 13, 2022 | PicoWay Laser SystemK220853 · GEX | 510(k) clearances |
| Dec 20, 2021 | Frax 1940 for Nordlys and Frax ProK212492 · GEX | 510(k) clearances |
| Dec 16, 2021 | Profound MatrixK211217 · GEI | 510(k) clearances |
| May 26, 2020 | GentleMax Pro PlusK201111 · GEX | 510(k) clearances |
| Sep 16, 2019 | PicoWay Laser SystemK191685 · GEX | 510(k) clearances |
| Sep 10, 2019 | Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.Class II · The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only | Device recalls |
| Sep 10, 2019 | Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.Class II · The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only | Device recalls |
| Sep 10, 2019 | Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.Class II · The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only | Device recalls |
| Sep 10, 2019 | Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.Class II · The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only | Device recalls |
| Feb 1, 2019 | Vbeam Prima Laser SystemK183452 · GEX | 510(k) clearances |
| Nov 6, 2013 | Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentClass II · Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
