Product code HJB— Ophthalmic

FDA has cleared 5 devices under product code HJB between 1985 and 1993, filed by 5 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.

• 19932 clearances
• 19862 clearances
• 19851 clearance

• R.H. Burton Co.1 clearance
• Marco Ophthalmic, Inc.1 clearance
• Kera Corp.1 clearance
• Heidelberg Instruments1 clearance
• Acufex Microsurgical, Inc.1 clearance

• K930444 — MARCO STANDARD KERATOMETERSMarco Ophthalmic, Inc.·1993-08-09
• K924779 — BURTON KERATOMETER - MODLE 2040R.H. Burton Co.·1993-04-05
• K864369 — LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNERHeidelberg Instruments·1986-12-15
• K864037 — KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZERKera Corp.·1986-11-13
• K852424 — ACUFEX COMPARATIVE SURGICAL KERATOMETERAcufex Microsurgical, Inc.·1985-09-11