LUMENIS, LTD.
LUMENIS, LTD. has 3 FDA enforcement events on this register (3 product records) between 2015 and 2025: 3 device; the busiest year was 2025 with 2.
0% of its events are Class I; the most common class is Class II (3). 2 events are listed as ongoing; the recalling firm's address is in N/A.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 22 Jul 2025 | OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue. | Device | Class II | 1 | Ongoing |
| 23 Jan 2025 | (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System. | Device | Class II | 1 | Ongoing |
| 17 Nov 2015 | Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971). | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has LUMENIS, LTD. had?
3 enforcement events (3 product records) on this register, 2015–2025: 3 device.
Are any LUMENIS, LTD. recalls ongoing?
2 events are listed as ongoing in the current openFDA export.
What class are LUMENIS, LTD. recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.