Candela Corp.: FDA filings under this applicant name

FDA lists 56 510(k) clearances under the applicant name “Candela Corp.” (first 1986, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 108 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Candela Corp. took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.

Top product codes

Review panels

• General and Plastic Surgery (55)
• Gastroenterology and Urology (1)

Most recent Candela Corp. 510(k) clearances

46 earlier clearances. See the full list in Caduvo.

Recalls

5 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-09-10.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Candela Corp. is the lead sponsor of 14 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:

• NCT06726122: Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment (Enrolling by invitation, started 2025-01-28)
• NCT06640998: Safety and Efficacy of Matrix Pro for Eyebrow Lift and Lift of Submental/Neck Laxity (Enrolling by invitation, started 2024-09-09)
• NCT06219278: A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles (Completed, started 2023-10-29)
• NCT06202274: Clinical Study to Evaluate the Safety and Efficacy of Candela Technology (Active not recruiting, started 2023-10-04)
• NCT06064071: Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD (Active not recruiting, started 2023-09-18)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Candela Laser Corp. (43 510(k)s)
• Candela Corpation (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Candela Corp.?

FDA lists 56 510(k) clearances under the applicant name “Candela Corp.” (first 1986, latest 2024), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Candela Corp.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Candela Corp. is 88 days. Since 2017: 108 days, versus 98 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Candela Corp.?

The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 53); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); FFK (Lithotriptor, Electro-Hydraulic, 1).

Next steps

• See all 56 Candela Corp. clearances with predicates and recalls
• Run predicate analysis for product code GEX, Candela Corp.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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