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.
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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