Total clearances
8
2022-05-18 → 2026-09-19
Name variants in FDA filings: Lumenis Be, Ltd. / Lumenis Be, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| GEX |
Powered Laser Surgical Instrument |
Class II |
General, Plastic Surgery |
5 |
2026-09-19 |
| GEI |
Electrosurgical, Cutting & Coagulation & Accessories |
Class II |
General, Plastic Surgery |
1 |
2026-06-02 |
| OAP |
Laser, Comb, Hair |
Class II |
Physical Medicine |
1 |
2023-06-14 |
| HQF |
Laser, Ophthalmic |
Class II |
Ophthalmic |
1 |
2022-07-15 |
Filings
All 510(k) clearances (8)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-09-19 |
K241973 |
SmartIPL_NI System |
GEX |
Class II |
General, Plastic Surgery |
| 2026-06-02 |
K253803 |
MILAN System |
GEI |
Class II |
General, Plastic Surgery |
| 2025-04-16 |
K250809 |
Stellar M22 |
GEX |
Class II |
General, Plastic Surgery |
| 2024-09-09 |
K242349 |
FoLix |
GEX |
Class II |
General, Plastic Surgery |
| 2023-12-01 |
K233301 |
ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories |
GEX |
Class II |
General, Plastic Surgery |
| 2023-06-14 |
K222790 |
F65 Laser System |
OAP |
Class II |
Physical Medicine |
| 2022-07-15 |
K220877 |
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems |
HQF |
Class II |
Ophthalmic |
| 2022-05-18 |
K220467 |
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories |
GEX |
Class II |
General, Plastic Surgery |