FDA-Device2025-09-03Class II
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Orascoptic Surgical Acuity
Hazard
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Sold states
Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.
Affected count
10,611 units
Manufactured in
717 W Collins Ave, Orange, CA, United States
Products
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2441-2025Don't want to check this manually?
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