HRM · Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
General, Plastic Surgery · 21 CFR 878.4700 · Class 1
Overview
| Product Code | HRM |
|---|---|
| Device Name | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
| Regulation | 21 CFR 878.4700 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932720 | HM-0970 | Hill-Med, Inc. | Sep 7, 1993 | SESE |
| K930439 | MARCO SURGISCOPE OPERATION MICROSCOPES | Marco Ophthalmic, Inc. | Jul 22, 1993 | SESE |
| K920641 | ALCON OPERATING MICROSCOPES | Alcon Laboratories | Oct 9, 1992 | SESE |
| K914956 | KEELER KONAN SPECULAR MICROSCOPE SP5500 | Keeler Instruments, Inc. | Feb 3, 1992 | SESE |
| K891584 | S 22 INSTRUMENT STAND | Carl Zeiss, Inc. | Jun 8, 1989 | SESE |
| K891001 | MICROSCOPE KNOB COVER, STERILE, DISPOSABLE | Prescott'S, Inc. | Apr 11, 1989 | SESE |
| K854440 | MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 | Keeler Instruments, Inc. | Dec 16, 1985 | SESE |
| K853855 | XTAL X-150 OPERATING MICROSCOPE | Xtal Corp. | Oct 15, 1985 | SESE |
| K852586 | CROMIC SURGICAL MICROSCOPE MODEL MC-1 | Seltrex, Corp. | Jul 30, 1985 | SESE |
| K852150 | CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 | Keeler Instruments, Inc. | Jun 3, 1985 | SESE |
| K850270 | CORNEAL LIGHT SHIELD | Mentor O & O, Inc. | May 31, 1985 | SESE |
| K844323 | KONAN CLINIC MICROSCOPE CLM-100-150 | Keeler Instruments, Inc. | Nov 21, 1984 | SESE |
| K822563 | OPHTHALMIC MICROSCOPE | Treace Medical, Inc. | Sep 14, 1982 | SESE |
| K792083 | HAAG-STREIT SLIT LAMP 900 | Lumenis, Inc. | Nov 16, 1979 | SESE |
Top Applicants
- Keeler Instruments, Inc. — 4 clearances
- Alcon Laboratories — 1 clearance
- Carl Zeiss, Inc. — 1 clearance
- Hill-Med, Inc. — 1 clearance
- Lumenis, Inc. — 1 clearance
