510(k) K923531

OPTOSCALPEL I LASER SYSTEM by Optomed Corp. — Product Code HQB

K923531 is an FDA 510(k) premarket notification submitted by Optomed Corp. for the device "OPTOSCALPEL I LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on November 12, 1993. The device falls under product code HQB (Photocoagulator And Accessories), a Class II device regulated under 21 CFR 886.4690. Optomed Corp. has at least 7 other 510(k) clearances on record.