Lumenis, Inc.
Lumenis, Inc. has 3 FDA enforcement events on this register (3 product records) between 2013 and 2021: 3 device; the busiest year was 2013 with 1.
33% of its events are Class I; the most common class is Class II (2). 0 events are listed as ongoing; the recalling firm's address is in UT.
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 |
|---|---|---|---|---|---|
| 14 Oct 2021 | IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical | Device | Class I | 1 | Terminated |
| 15 Aug 2014 | Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural… | Device | Class II | 1 | Terminated |
| 19 Aug 2013 | Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology. | Device | Class II | 1 | Terminated |
By type and class
Class I: 33% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Lumenis, Inc. had?
3 enforcement events (3 product records) on this register, 2013–2021: 3 device.
Are any Lumenis, Inc. recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are Lumenis, Inc. recalls?
2 Class II, 1 Class I. 33% 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.