Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Syneron MedicalLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Candela Corporation with 56 510(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
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
