Product code HJI— Ophthalmic

FDA has cleared 8 devices under product code HJI between 1976 and 1992, filed by 7 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.

• 19921 clearance
• 19903 clearances
• 19821 clearance
• 19812 clearances
• 19761 clearance

• Cooper Medical Devices Corp.2 clearances
• Richard'S Medical Equip., Inc.1 clearance
• Optical Micro Systems, Inc.1 clearance
• Ocular Instruments, Inc.1 clearance
• Innovision Medical, Inc.1 clearance
• Canon USA, Inc.1 clearance
• Academic Catalyst Corp.1 clearance

• K923670 — BYRNE EXPULSIVE LENSOcular Instruments, Inc.·1992-11-16
• K901839 — 60 FUNDUS CAMERA CF-60UVCanon USA, Inc.·1990-07-05
• K902138 — STRIPE PROJECTORAcademic Catalyst Corp.·1990-07-05
• K897186 — LASER IMAGING WORK STATIONInnovision Medical, Inc.·1990-03-12
• K820223 — OMS QUARTZ INFUSION CONTACT LENSOptical Micro Systems, Inc.·1982-02-05
• K802927 — SEBESTYEN IRRIGATING CONTACT LENSCooper Medical Devices Corp.·1981-02-05
• K802971 — LANDERS CONTACT LENSCooper Medical Devices Corp.·1981-02-05
• K760949 — CHARLES IRRIGATING FUNDUS CONTACT LENSRichard'S Medical Equip., Inc.·1976-11-11