Product code HQA— Ophthalmic

ACU220 CRYO UNIT

Classification name: Unit, Cryotherapy, Ophthalmic
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Total cleared: 4
First cleared: 1983-01-17
Most recent: 1985-12-30

Market context for product code HQA

FDA has cleared 4 devices under product code HQA between 1983 and 1985, filed by 2 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.

Clearances per year

19852 clearances
19841 clearance
19831 clearance

Top applicants under product code HQA

Keller Instruments, Inc.2 clearances
Keeler Instruments, Inc.2 clearances

Recent clearances under product code HQA

K854411 — KEELER-COMPACT CRYO SYSTEMKeeler Instruments, Inc.·1985-12-30
K854422 — SERIES 25 SLIMLINE CRYO PROBESKeeler Instruments, Inc.·1985-12-30
K841294 — ACU220 CRYO UNITKeller Instruments, Inc.·1984-08-15
K823835 — SPEMBLY 140 CRYOSYSTEM PROBES & TIPSKeller Instruments, Inc.·1983-01-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.