Cynosure, Inc.: FDA filings under this applicant name

FDA lists 107 510(k) clearances under the applicant name “Cynosure, Inc.” (first 1992, latest 2026), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 85 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 Cynosure, Inc. took a median 85 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 (102)
• Physical Medicine (5)

Most recent Cynosure, Inc. 510(k) clearances

97 earlier clearances. See the full list in Caduvo.

Recalls

1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-10-09.

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 Cynosure, Inc. is the lead sponsor of 44 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:

• NCT05847530: Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions (Completed, started 2023-08-17)
• NCT05987319: Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions (Recruiting, started 2023-07-24)
• NCT06023303: Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin (Completed, started 2023-06-21)
• NCT05590039: Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure (Completed, started 2022-07-08)
• NCT05388604: Clinical Study To Evaluate Paired Treatment With An Alexandrite Laser And Radiofrequency Microneedling For Facial Aging (Completed, started 2022-06-15)

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.

• Cynosure, Inc. Dba Ellman (1 510(k)s)
• Cynosure Lutronic Technology Corporation (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Cynosure, Inc.?

FDA lists 107 510(k) clearances under the applicant name “Cynosure, Inc.” (first 1992, latest 2026), across 10 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 Cynosure, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Cynosure, Inc. is 88 days. Since 2017: 85 days, versus 98 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Cynosure, Inc.?

The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 84); PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use, 6); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 5).

Next steps

• See all 107 Cynosure, Inc. clearances with predicates and recalls
• Run predicate analysis for product code GEX, Cynosure, Inc.'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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