510(k) Report

FDA applicant

Candela Corp.

Wayland, MA56 decisions1986–20244 recalls

FDA records 56 decisions for Candela Corp. (Wayland, MA) from 1986 to 2024: 56 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 109 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 129 predicates, 65 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Candela Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Candela Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 22008: 22011: 22013: 12014: 22015: 12019: 22020: 12021: 22022: 12023: 12024: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2013

2007: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Candela Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Candela Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument53decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • FFKLithotriptor, Electro-Hydraulic1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 109 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 4 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 129 predicates; 65 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 176 times; 65 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K994260Candela Gentlelase GL Dermatological LaserCandela Corp. · 200011cite it
  • K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 200310cite it
  • K191685PicoWay Laser SystemCandela Corporation · 20198cite it
  • K150326PicoWay Laser SystemCandela Corporation · 20156cite it
  • K024371Candela Gentle Lase Family of Laser SystemCandela Corp. · 20036cite it
  • K024260Candela Gentlelase Family of Laser SystemsCandela Corp. · 20036cite it

What has FDA decided for it lately?

  • K240070Profound MatrixCandela Corporation · 2024
  • K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation · 2023
  • K220853PicoWay Laser SystemCandela Corporation · 2022
  • K212492Frax 1940 for Nordlys and Frax ProCandela Corporation · 2021
  • K211217Profound MatrixCandela Corporation · 2021
  • K201111GentleMax Pro PlusCandela Corporation · 2020
  • K191685PicoWay Laser SystemCandela Corporation · 2019
  • K183452Vbeam Prima Laser SystemCandela Corp. · 2019

All 48 as Candela Corp. →All 8 as Candela Corporation →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K024260Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use -…Nov 6, 2013Class II
  • K050673Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam…Jan 15, 2007
  • K050673Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology…Jan 17, 2006
  • K022884Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820…Nov 25, 2003

Other applicant names beginning “Candela”

FDA records each applicant name separately; these may or may not be the same firm.

Candela Laser Corp. 43Candela Corpation 1