HQA — Unit, Cryotherapy, Ophthalmic Class II

FDA Device Classification

FDA product code HQA covers "Unit, Cryotherapy, Ophthalmic", a Class II medical device regulated under 21 CFR 886.4170. Submissions are reviewed by the Ophthalmic panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HQA
Device Class
Class II
Regulation Number
886.4170
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K854411keeler instrumentsKEELER-COMPACT CRYO SYSTEMDecember 30, 1985
K854422keeler instrumentsSERIES 25 SLIMLINE CRYO PROBESDecember 30, 1985
K841294keller instrumentsACU220 CRYO UNITAugust 15, 1984
K823835keller instrumentsSPEMBLY 140 CRYOSYSTEM PROBES & TIPSJanuary 17, 1983