FDA-Device2025-08-27Class II
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
LUMENIS, LTD.
Hazard
The potential for unsterilized product within finished product labeled as sterile.
Sold states
Domestic: PA, WI; International: Germany, India;
Affected count
13 units
Manufactured in
Yokneam Ind. Park, 6, Ha-Kidma, Yokne'Am Ilit, N/A, Israel
Products
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2344-2025Don't want to check this manually?
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