Product code HPA— Ophthalmic

FDA has cleared 5 devices under product code HPA between 1982 and 1985, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19852 clearances
• 19842 clearances
• 19821 clearance

• Ascon Medical Instruments, Ltd.2 clearances
• Woodlyn, Inc.1 clearance
• Michael Onufryk1 clearance
• Medical Equipment Designs, Inc.1 clearance

• K852548 — ATL 225 MW TRAIL LENS SETAscon Medical Instruments, Ltd.·1985-07-31
• K852126 — ATF 101 TRAIL FRAMEAscon Medical Instruments, Ltd.·1985-06-05
• K841768 — WOODLYN LIGHTWEIGHT TRIAL FRAMEWoodlyn, Inc.·1984-06-01
• K833669 — IMAGE DEFLECTORMichael Onufryk·1984-03-27
• K821084 — UNIVERSAL TRIAL FRAMEEMedical Equipment Designs, Inc.·1982-06-14