Medical Device Manufacturer · US , Auburn , MA

Polytec Pi, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1994

Recent clearances: LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM, LASEAWAY Q-SWITCHED RUBY LASER SYSTEM

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Polytec Pi, Inc. General & Plastic Surgery ✕

2 devices

1-2 of 2

Cleared Jun 24, 1997

LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM

General & Plastic Surgery · 84d

Cleared Jul 08, 1994

LASEAWAY Q-SWITCHED RUBY LASER SYSTEM

General & Plastic Surgery · 53d