Lumenis, Inc.: FDA filings under this applicant name
FDA lists 75 510(k) clearances under the applicant name “Lumenis, Inc.” (first 1979, latest 2022), plus 2 PMA and 1 De Novo decisions, across 12 product codes in 4 review panels. Median 510(k) review time under this name: 86 days. Since 2017 the median was 58 days, against 99 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 | 0 | — |
| 2013 | 3 | 243 |
| 2014 | 3 | 143 |
| 2015 | 4 | 77 |
| 2016 | 0 | — |
| 2017 | 4 | 178 |
| 2018 | 1 | 28 |
| 2019 | 0 | — |
| 2020 | 4 | 28 |
| 2021 | 1 | 54 |
| 2022 | 1 | 361 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lumenis, Inc. took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 60 | 60 |
| FTC | Light, Ultraviolet, Dermatological | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| HQF | Laser, Ophthalmic | 3 | 3 |
| MVF | System, Laser, Photodynamic Therapy | 2 | 0 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 1 | 1 |
| ODF | Mini Endoscope, Gastroenterology-Urology | 1 | 1 |
Plus 2 more product codes.
Review panels
- General and Plastic Surgery (71)
- Ophthalmic (5)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
Most recent Lumenis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211979 | Lumenis Y&R Laser System | GEX | 2022-06-21 | 361 |
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | GEX | 2021-10-19 | 54 |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories | GEX | 2020-12-24 | 20 |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | GEX | 2020-10-22 | 58 |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | GEX | 2020-07-16 | 27 |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | GEX | 2020-01-16 | 30 |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | GEX | 2018-04-03 | 28 |
| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | GEX | 2017-09-18 | 242 |
| K170060 | M22 and ResurFx Systems | GEX | 2017-08-09 | 215 |
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | GEX | 2017-05-22 | 129 |
65 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200028 | De Novo | Intense Pulsed Light Device For Managing Dry Eye | 2021-02-23 |
| P990049 | PMA | COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM | 2000-04-12 |
| P940011 | PMA | COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS | 1995-12-27 |
Recalls
13 product recalls in 13 recall events; 3 initiated in the last five years. Most recent: 2025-07-22.
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.
- Lumenis Be, Ltd. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lumenis, Inc.?
FDA lists 75 510(k) clearances under the applicant name “Lumenis, Inc.” (first 1979, latest 2022), plus 2 PMA and 1 De Novo decisions, across 12 product codes in 4 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 Lumenis, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lumenis, Inc. is 86 days. Since 2017: 58 days, versus 99 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Lumenis, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 60); FTC (Light, Ultraviolet, Dermatological, 3); GCJ (Laparoscope, General & Plastic Surgery, 3).
Next steps
- See all 75 Lumenis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Lumenis, 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.