FDA applicant

Candela Laser Corp.

Wayland, MA43 decisions1988–19960 recalls

FDA records 43 decisions for Candela Laser Corp. (Wayland, MA) from 1988 to 1996: 43 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GEH (Unit, Cryosurgical, Accessories). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

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 Laser Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Candela Laser Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Candela Laser 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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Other applicant names beginning “Candela”

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

Candela Corp. 56 Candela Corpation 1

Candela Laser Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Candela”