Product code HQN— Ophthalmic

FDA has cleared 7 devices under product code HQN between 1977 and 1998, filed by 6 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.

• 19981 clearance
• 19972 clearances
• 19951 clearance
• 19922 clearances
• 19771 clearance

• Storz Instrument Co.2 clearances
• Xavier A. Guerra, Ocularist, Inc.1 clearance
• Southwest Artificial Eyes, Inc.1 clearance
• Robert B. Scott Ocularists of Florida, Inc.1 clearance
• Porex Surgical, Inc.1 clearance
• Kolberg Ocular Products, Inc.1 clearance

• K972034 — MEDPOR OCULAR CONFORMERPorex Surgical, Inc.·1998-01-20
• K970318 — OCULAR CONFORMERSouthwest Artificial Eyes, Inc.·1997-07-07
• K970319 — OCULAR CONFORMERXavier A. Guerra, Ocularist, Inc.·1997-07-07
• K945110 — KOLBERG OPHTHALMIC CONFORMERKolberg Ocular Products, Inc.·1995-01-13
• K921221 — STERILE/SINGLE USE SYMBLEPHARON RINGStorz Instrument Co.·1992-07-17
• K921229 — STERILE/SINGLE USE OPHTHALMIC CONFORMERSStorz Instrument Co.·1992-06-09
• K772168 — MOLDEYERobert B. Scott Ocularists of Florida, Inc.·1977-11-30