HRM · Class I · 21 CFR 878.4700

FDA Product Code HRM: Microscope, Operating & Accessories, Ac-powered, Ophthalmic

Leading manufacturers include Keeler Instruments, Inc., Lumenis, Inc. and Treace Medical, Inc..

14
Total
14
Cleared
75d
Avg days
1979
Since

FDA 510(k) Cleared Microscope, Operating & Accessories, Ac-powered, Ophthalmic Devices (Product Code HRM)

14 devices
1–14 of 14
Cleared Oct 09, 1992
ALCON OPERATING MICROSCOPES
K920641
Alcon Laboratories
General & Plastic Surgery · 240d
Cleared Feb 03, 1992
KEELER KONAN SPECULAR MICROSCOPE SP5500
K914956
Keeler Instruments, Inc.
General & Plastic Surgery · 90d
Cleared Jun 08, 1989
S 22 INSTRUMENT STAND
K891584
Carl Zeiss, Inc.
General & Plastic Surgery · 80d
Cleared Dec 16, 1985
MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50
K854440
Keeler Instruments, Inc.
General & Plastic Surgery · 41d
Cleared Jun 03, 1985
CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500
K852150
Keeler Instruments, Inc.
General & Plastic Surgery · 17d
Cleared Nov 21, 1984
KONAN CLINIC MICROSCOPE CLM-100-150
K844323
Keeler Instruments, Inc.
General & Plastic Surgery · 14d
Cleared Sep 14, 1982
OPHTHALMIC MICROSCOPE
K822563
Treace Medical, Inc.
General & Plastic Surgery · 21d
Cleared Nov 16, 1979
HAAG-STREIT SLIT LAMP 900
K792083
Lumenis, Inc.
General & Plastic Surgery · 31d

About Product Code HRM - Regulatory Context