Product code HOE— Ophthalmic

FDA has cleared 7 devices under product code HOE between 1978 and 1988, 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.

• 19881 clearance
• 19822 clearances
• 19811 clearance
• 19801 clearance
• 19791 clearance
• 19781 clearance

• V. Mueller O.V. Baxter Healthcare Corp.1 clearance
• Koi, Inc.1 clearance
• Edward Weck, Inc.1 clearance
• Design Research Assoc., Inc.1 clearance
• CooperVision, Inc.1 clearance
• Aztec Medical Products, Inc.1 clearance
• Accutome, Inc.1 clearance

• K881094 — KOI(TM) BLADE GAUGE, MODEL KOI-132CooperVision, Inc.·1988-04-01
• K813315 — CALIPER-OPTHALMICDesign Research Assoc., Inc.·1982-03-01
• K820050 — KREMER BLADE GAUGEAccutome, Inc.·1982-02-24
• K812011 — BLADE GAUGEKoi, Inc.·1981-07-28
• K801937 — BLEPHAROMETERAztec Medical Products, Inc.·1980-09-16
• K792383 — KELMAN DIPSTICKV. Mueller O.V. Baxter Healthcare Corp.·1979-12-11
• K781715 — RULER, WECK SCOTTEdward Weck, Inc.·1978-12-04