Cutera, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Cutera, Inc.” (first 2004, latest 2025), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 87 days. Since 2017 the median was 78 days, against 102 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 87 |
| 2013 | 2 | 208 |
| 2014 | 3 | 231 |
| 2015 | 0 | — |
| 2016 | 3 | 92 |
| 2017 | 3 | 30 |
| 2018 | 2 | 61 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 3 | 58 |
| 2023 | 2 | 83 |
| 2024 | 0 | — |
| 2025 | 1 | 88 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cutera, Inc. took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 20 | 20 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| NUV | Massager, Vacuum, Light Induced Heating | 2 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 | 1 |
Review panels
Most recent Cutera, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251149 | AviClear Laser System | GEX | 2025-07-11 | 88 |
| K233237 | xeo+ Family | GEX | 2023-12-15 | 78 |
| K230660 | AviClear Laser System | GEX | 2023-06-06 | 88 |
| K223110 | truSculpt iD | GEI | 2022-11-03 | 31 |
| K221407 | truSculpt iD | GEI | 2022-07-13 | 58 |
| K213461 | AviClear Laser System | GEX | 2022-03-24 | 148 |
| K182997 | enlighten III Laser System | GEX | 2018-12-12 | 43 |
| K180709 | truSculpt RF Device; truSculpt; truSculpt 3D | PBX | 2018-06-06 | 79 |
| K172077 | Cutera enlighten III Laser System | GEX | 2017-10-27 | 109 |
| K172004 | truSculpt | PBX | 2017-08-02 | 30 |
21 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2013-10-16.
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 Cutera, Inc. is the lead sponsor of 36 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06469398: A Post Market Device Study for the Treatment of Acne (Active not recruiting, started 2022-07-21)
- NCT04695691: A Device Study for the Treatment of Acne (Completed, started 2020-12-15)
- NCT03782545: Multi-Center Pilot Study of Cutera truSculpt Device (Completed, started 2018-05-11)
- NCT03424148: Open-label, Prospective, Multicenter Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment (Completed, started 2018-02-20)
- NCT03424161: Multi-Center, Clinical Evaluation of the Cutera Secret RF Device (Completed, started 2018-01-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cutera, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Cutera, Inc.” (first 2004, latest 2025), across 6 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 Cutera, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cutera, Inc. is 87 days. Since 2017: 78 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cutera, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 20); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 5); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Next steps
- See all 31 Cutera, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Cutera, 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.