Lumenis Be, Ltd.: FDA clearances and approvals
Lumenis Be, Ltd. has 8 FDA 510(k) clearances (first 2022, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time: 101 days. Since 2017 its median was 101 days, against 97 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 18 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 2 | 101 |
| 2023 | 2 | 168 |
| 2024 | 1 | 32 |
| 2025 | 1 | 30 |
| 2026 | 2 | 496 |
Review time against the same product codes
Since 2017, Lumenis Be, Ltd.'s cleared 510(k)s took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
| OAP | Laser, Comb, Hair | 1 | 1 |
Review panels
Most recent Lumenis Be, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241973 | SmartIPL_NI System | GEX | 2026-09-19 | 806 |
| K253803 | MILAN System | GEI | 2026-06-02 | 186 |
| K250809 | Stellar M22 | GEX | 2025-04-16 | 30 |
| K242349 | FoLix | GEX | 2024-09-09 | 32 |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories | GEX | 2023-12-01 | 63 |
| K222790 | F65 Laser System | OAP | 2023-06-14 | 272 |
| K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | HQF | 2022-07-15 | 112 |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories | GEX | 2022-05-18 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Lumenis Be, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Lumenis Be, Ltd. is the industry lead sponsor of 18 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06885112: Clinical Study to Evaluate the Improvement in Hair Loss in Skin of Color Treated With Fractional Non-Ablative Laser (Recruiting, started 2025-02-21)
- NCT05945069: Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects with Dry Eye Disease (Completed, started 2023-08-01)
- NCT05957029: Evaluation of Thermal Outcome and Safety of Nuera Tight RF System (Completed, started 2023-06-22)
- NCT05755139: Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL (Completed, started 2022-12-04)
- NCT05487547: Feasibility of IPL Combined With RF for Treatment of DED Due to MGD (Completed, started 2022-07-21)
Frequently asked questions
How many FDA 510(k) clearances does Lumenis Be, Ltd. have?
Lumenis Be, Ltd. has 8 FDA 510(k) clearances (first 2022, latest 2026), across 4 product codes in 2 review panels.
How long does FDA take to clear Lumenis Be, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Lumenis Be, Ltd.'s cleared 510(k)s is 101 days. Since 2017: 101 days, versus 97 days for all cleared 510(k)s in the same product codes.
What devices does Lumenis Be, Ltd. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 5); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); HQF (Laser, Ophthalmic, 1).
Has Lumenis Be, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lumenis Be, Ltd. Related entities may recall under other names.
Next steps
- See all 8 Lumenis Be, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Lumenis Be, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.