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Candela Laser Corp.

United StatesFDA applicant, unverified

Devices
43
FDA recalls
8

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Candela Laser Corp. makes

Candela Laser Corp. manufactures laser systems and accessories for ophthalmology and urology, including diode trabeculoplasty lasers for glaucoma treatment, pulsed dye lasers for vascular lesion therapy, and Q-switched alexandrite lasers for pigmented lesion removal. The company also produces endoscopic tools like the directable biliary catheter system and cryo-probe holders for medical procedures. Stone baskets for lithotripsy and erbium lasers for soft tissue ablation are part of its portfolio, alongside specialized handpieces and mini-endoscopes for targeted medical interventions.

The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. These devices are listed in the FDA’s 510(k) registry, reflecting their authorised status for commercial distribution in the United States. Candela Laser Corp. is headquartered in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue43

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FDA recalls8

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 8 recalls initiated by Candela Laser Corp., the earliest on 2003-11-25 and the most recent on 2007-01-15. By recorded status: 8 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2007

    • 15 Jan 2007 Z-0508-2007 Unclassified (pre-2012) Terminated Internal component may overheat causing the possibility of risk of fire or smoke Distribution: Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico Submission number: K050673
    • 15 Jan 2007 Z-0509-2007 Unclassified (pre-2012) Terminated Internal component may overheat causing the possibility of risk of fire or smoke Distribution: Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico
    • 15 Jan 2007 Z-0510-2007 Unclassified (pre-2012) Terminated Internal component may overheat causing the possibility of risk of fire or smoke Distribution: Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico
    • 15 Jan 2007 Z-0511-2007 Unclassified (pre-2012) Terminated Internal component may overheat causing the possibility of risk of fire or smoke Distribution: Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico
    • 15 Jan 2007 Z-0512-2007 Unclassified (pre-2012) Terminated Internal component may overheat causing the possibility of risk of fire or smoke Distribution: Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico
    • 15 Jan 2007 Z-0513-2007 Unclassified (pre-2012) Terminated Internal component may overheat causing the possibility of risk of fire or smoke Distribution: Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico

  • 2006

    • 17 Jan 2006 Z-0842-06 Unclassified (pre-2012) Terminated Handle fires even when the finger is off the switch Distribution: Nationwide Foreign: Canada, Spain, Japan, Germany, France, Switzerland Submission numbers: K050673, K051359

  • 2003

    • 25 Nov 2003 Z-0291-04 Unclassified (pre-2012) Terminated Laser may pulse and not dispense cryogen resulting in patient injury Distribution: Nationwide Foreign: Canada,Thailand, Germany, Spain , Japan, Italy, Greece, Saudi Arabia, UK, France, Switzerland,…
      Full distribution text Nationwide Foreign: Canada,Thailand, Germany, Spain , Japan, Italy, Greece, Saudi Arabia, UK, France, Switzerland, Mexico, Ukraine, Kuwait, Netherlands.
      Submission numbers: K022884, K013825, K030834, K030846

Frequently asked questions

How many devices does Candela Laser Corp. have in the registry?

The registry currently lists 43 devices for Candela Laser Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Candela Laser Corp.'s devices?

Among its 43 most recently registered devices, Candela Laser Corp. has devices listed in FDA 510(k) (43 devices).

What risk classes do Candela Laser Corp.'s devices fall under?

Among its 43 most recently registered devices, the classes recorded for Candela Laser Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Candela Laser Corp.?

FDA recall records list 8 recalls initiated by Candela Laser Corp., the most recent initiated on 15 Jan 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Candela Laser Corp. in the registry?

The most recently registered devices listed for Candela Laser Corp. include CANDELA DIODE TRABECULOPLASTY LASER DTL, CANDELA DIRECTABLE BILIARY CATHETER SYSTEM, CANDELA CRYO-PROBE HOLDER and CANDELA SPTL PULSED DYE LASERS.

Generated automatically from registry data and not verified by a human reviewer.