HPS · Class II · 21 CFR 886.4170

FDA Product Code HPS: Unit, Cryophthalmic

Leading manufacturers include Keeler Instruments, Inc., Spembly Medical , Ltd. and Mira, Inc..

11
Total
11
Cleared
104d
Avg days
1979
Since

FDA 510(k) Cleared Unit, Cryophthalmic Devices (Product Code HPS)

11 devices
1–11 of 11
Cleared Dec 30, 2020
CryoTreQ
K202038
Vitreq BV
Ophthalmic · 160d
Cleared Jul 18, 1994
OPHTHALMIC CRYO UNIT
K940373
Dutch Ophthalmic USA, Inc.
Ophthalmic · 173d
Cleared Oct 19, 1992
OPHTHALMIC TRICHIASIS PROBE
K923629
Mira, Inc.
Ophthalmic · 90d
Cleared Oct 11, 1990
SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES
K903303
Spembly Medical , Ltd.
Ophthalmic · 79d
Cleared Jan 29, 1988
KEELER ACU 22XT OPHTHALMIC CRYO UNIT
K874555
Keeler Instruments, Inc.
Ophthalmic · 86d
Cleared Nov 13, 1987
KEELER CTU CRYO SYSTEM
K873388
Keeler Instruments, Inc.
Ophthalmic · 81d
Cleared Feb 20, 1987
UNITED SURGICAL CORP. CRYOPTIC PLUS
K870195
United Surgical Corp.
Ophthalmic · 31d
Cleared Feb 12, 1979
BEAVER CATARACT CYROXTRACTOR
K781338
Edward Weck, Inc.
Ophthalmic · 192d
Cleared Feb 12, 1979
MODEL 556-01 CRYOEXTRACTOR
K790102
Intermedics, Inc.
Ophthalmic · 27d

About Product Code HPS - Regulatory Context