Medical Device Manufacturer · US , Mchenry , IL

Lasertek OY - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1979

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lasertek OY Ophthalmic ✕

3 devices

1-3 of 3

Cleared Jan 30, 1984

MODEL 150K LASER COAGULATOR

Ophthalmic · 221d

Cleared Feb 08, 1979

LASER COAGULATOR, MODEL 41AK

Ophthalmic · 76d

Cleared Feb 08, 1979

COAGULATOR, MODEL 40 AARGON

Ophthalmic · 57d