510(k) K123056

PASCAL LASER INDIRECT OPHTHALMOSCOPE by Topcon Medical Laser Systems, Inc. (Tmls) — Product Code HQF

K123056 is an FDA 510(k) premarket notification submitted by Topcon Medical Laser Systems, Inc. (Tmls) for the device "PASCAL LASER INDIRECT OPHTHALMOSCOPE". The FDA issued a decision of Substantially Equivalent on Nov 13, 2012. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Topcon Medical Laser Systems, Inc. (Tmls) has 1 other 510(k) clearance on record.