Product code HPJ— Ophthalmic

FDA has cleared 5 devices under product code HPJ between 1978 and 1986, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19861 clearance
• 19851 clearance
• 19822 clearances
• 19781 clearance

• Randwal Instrument Co., Inc.2 clearances
• Coherent Medical Division1 clearance
• Coburn Optical Ind., Inc.1 clearance
• American Laser Corp.1 clearance

• K864012 — IRAS PERIMETERRandwal Instrument Co., Inc.·1986-12-12
• K853556 — LASER IRASRandwal Instrument Co., Inc.·1985-11-01
• K822415 — THE OCUPLOT DCoherent Medical Division·1982-09-07
• K813429 — LASER PHOTOCOAGULATOR ARGON MED. LASERAmerican Laser Corp.·1982-01-22
• K781507 — RETINOMETERCoburn Optical Ind., Inc.·1978-11-15