Lutronic Corporation: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Lutronic Corporation” (first 2007, latest 2025), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 154 days. Since 2017 the median was 182 days, against 103 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 | 4 | 160 |
| 2013 | 2 | 350 |
| 2014 | 1 | 147 |
| 2015 | 0 | — |
| 2016 | 1 | 280 |
| 2017 | 2 | 135 |
| 2018 | 2 | 220 |
| 2019 | 1 | 175 |
| 2020 | 0 | — |
| 2021 | 1 | 88 |
| 2022 | 2 | 202 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 158 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lutronic Corporation took a median 182 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 20 | 20 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 2 | 2 |
| HQF | Laser, Ophthalmic | 1 | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 | 1 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 | 1 |
Review panels
Most recent Lutronic Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251327 | XERF | GEI | 2025-08-11 | 103 |
| K244060 | eCO2 3D | ONG | 2025-07-31 | 212 |
| K213748 | CoreLevee | NGX | 2022-10-14 | 318 |
| K213569 | HOLLYWOOD SPECTRA Laser System | GEX | 2022-02-04 | 87 |
| K203788 | DermaV Laser System | GEX | 2021-03-26 | 88 |
| K183566 | CLARITY II Laser System | GEX | 2019-06-14 | 175 |
| K180945 | LUTRONIC GENIUS Radiofrequency System | GEI | 2018-12-10 | 243 |
| K173700 | PICOPLUS Laser System | GEX | 2018-06-19 | 197 |
| K171009 | LASEMD Laser System | GEX | 2017-06-23 | 80 |
| K163196 | ACTION II Laser System | GEX | 2017-05-24 | 190 |
19 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 3 initiated in the last five years. Most recent: 2026-08-06.
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.
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.
- Lutronic Aesthetic (1 510(k)s)
- Lutronic Global (1 510(k)s)
- Lutronic Vision, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lutronic Corporation?
FDA lists 29 510(k) clearances under the applicant name “Lutronic Corporation” (first 2007, latest 2025), across 7 product codes in 3 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 Lutronic Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lutronic Corporation is 154 days. Since 2017: 182 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Lutronic Corporation?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 20); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output, 2).
Next steps
- See all 29 Lutronic Corporation clearances with predicates and recalls
- Run predicate analysis for product code GEX, Lutronic Corporation'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.