Product code HRJ— Ophthalmic

FDA has cleared 7 devices under product code HRJ between 1984 and 1993, 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.

• 19931 clearance
• 19921 clearance
• 19911 clearance
• 19852 clearances
• 19842 clearances

• Woodlyn, Inc.1 clearance
• Techna Vision1 clearance
• R.H. Burton Co.1 clearance
• Optical Micro Systems, Inc.1 clearance
• Marco Ophthalmic, Inc.1 clearance
• Dentsply Intl.1 clearance
• Alcon Laboratories1 clearance

• K930447 — MARCO H AND TS-1 INSTRUMENT TABLESMarco Ophthalmic, Inc.·1993-07-06
• K922242 — 910T MONTORIZED INSTRUMENT TABLER.H. Burton Co.·1992-09-30
• K912134 — TBD, LENS MEASURING DEVICEAlcon Laboratories·1991-07-25
• K853744 — TECHNA VISION, INC.ELECTRIC TABLETechna Vision·1985-10-17
• K853359 — RELIANCE 1379Dentsply Intl.·1985-09-24
• K841760 — WOODLYN CLASSIC INSTRUMENT STANDWoodlyn, Inc.·1984-06-19
• K833820 — MACHEMER/TANO ROTATINGOptical Micro Systems, Inc.·1984-01-04