Product code HQT— Ophthalmic

FDA has cleared 4 devices under product code HQT between 1986 and 1997, 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.

• 19972 clearances
• 19911 clearance
• 19861 clearance

• Xavier A. Guerra, Ocularist, Inc.1 clearance
• Southwest Artificial Eyes, Inc.1 clearance
• Mira, Inc.1 clearance
• Midwest Eye Laboratories, Inc.1 clearance

• K970320 — SCLERAL SHELLXavier A. Guerra, Ocularist, Inc.·1997-07-07
• K970327 — SCLERAL SHELLSouthwest Artificial Eyes, Inc.·1997-07-07
• K904961 — ARTIFICIAL SCLERAL SHELLMidwest Eye Laboratories, Inc.·1991-08-30
• K855105 — SIMMONS SHELLMira, Inc.·1986-03-31