Product code HRG— Ophthalmic

FDA has cleared 6 devices under product code HRG between 1979 and 2001, filed by 6 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.

• 20011 clearance
• 19981 clearance
• 19851 clearance
• 19841 clearance
• 19831 clearance
• 19791 clearance

• Scanlan Intl., Inc.1 clearance
• Optical Systems Intl., Inc.1 clearance
• Laser Center Dev. Corp.1 clearance
• Intl. Ophthalmic Industries Corp.1 clearance
• Edward Weck, Inc.1 clearance
• Bkg Opthalmics USA, Inc.1 clearance

• K013151 — ASMOTOM AUTOMATED TREPHINE SYSTEMBkg Opthalmics USA, Inc.·2001-12-14
• K981063 — AUTOMATED CORNEAL TREPHINELaser Center Dev. Corp.·1998-06-23
• K843957 — ULTRATHIN/SP LENSOptical Systems Intl., Inc.·1985-07-31
• K841515 — SCANLAN VASCU-STATT IIScanlan Intl., Inc.·1984-06-05
• K823901 — TREPHINE BLADES-VARIOUS MODELSEdward Weck, Inc.·1983-01-17
• K791763 — (MICRO-KERATRON, MICRO DUCT TREPHINE)Intl. Ophthalmic Industries Corp.·1979-11-05