Data / Medical devices / United States / Lumenis Be Inc.
Lumenis Be Inc.: FDA-registered device maker in Salt Lake City, UT, United States, 4 510(k) clearances
Lumenis Be Inc. is registered with the FDA (registration 3020611964) in Salt Lake City, UT, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 15, 2022. 5 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020611964
- FEI number
- 1720381
- Address
- 1870 South Milestone Drive, Salt Lake City, UT, United States, 84104
- Owner or operator
- Lumenis Be Ltd. (10082799)
- Roles
- Manufacturer
- First device listed
- October 10, 2021
- Registered through
- 2026
- Brand names listed
- Array LaserLink, Digital Duet, Digital Trio, Eye Safety Filter Kit, LaserLink HS, LaserLink S Kit, LaserLink Z, Selecta Duet and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Ophthalmic | HQF | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 15, 2022 | K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | HQF | Substantially Equivalent | Lumenis Be, Inc. | accessdata.fda.gov |
| February 28, 2017 | K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| October 30, 2015 | K151109 | Lumenis Smart532 Laser System | GEX | Substantially Equivalent | Lumenis, Inc. | accessdata.fda.gov |
| July 25, 2011 | K111213 | VISION ONE LASER SYSTEM | GEX | Substantially Equivalent | Lumenis, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 14, 2021 | 88863 | Class I | Terminated | 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 | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-l | accessdata.fda.gov |
| August 15, 2014 | 69139 | Class II | Terminated | 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 i | Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern. | accessdata.fda.gov |
| August 19, 2013 | 66133 | Class II | Terminated | Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology. | Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user. | accessdata.fda.gov |
| July 27, 2010 | 56481 | Not yet classified | Terminated | Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO | Firm did not have proper 510(K) clearance. | accessdata.fda.gov |
| December 18, 2007 | 46251 | Not yet classified | Terminated | Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No., Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL. | Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size. | accessdata.fda.gov |
Compare with other makers
Updated July 15, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.