Panels › General, Plastic Surgery › Product code HRM · Class 1
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Regulation 878.4700
0510(k)s in 12 months (14 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in HRM
| Company | 510(k)s | Recalls |
|---|---|---|
| Keeler Instruments, Inc. | 4 | 0 |
| Leica Microsystems, Inc. | 0 | 3 |
| Alcon Research, Ltd. | 0 | 2 |
| Alcon Laboratories | 1 | 0 |
| Alcon Research Laboratories Ltd. | 0 | 1 |
| Carl Zeiss, Inc. | 1 | 0 |
| Haag-Streit USA Inc | 0 | 1 |
| Hill-Med, Inc. | 1 | 0 |
| Lumenis, Inc. | 1 | 0 |
| Marco Ophthalmic, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2022 | Leica Microsystems, Inc. Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system Open, Classified |
HRM | None listed |
| Nov 20, 2020 | Haag-Streit USA Inc Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. Open, Classified |
HRM | None listed |
| Feb 27, 2019 | Alcon Research Laboratories Ltd. Alcon or Endure Ophthalmic Microscope
Product Usage:
Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea. Terminated |
HRM | None listed |
| Jan 2, 2019 | Leica Microsystems, Inc. Leica M220 F12 surgical microscope
The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied f Terminated |
HRM | None listed |
| Sep 25, 2017 | Leica Microsystems, Inc. PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for hu Terminated |
HRM | None listed |
| May 25, 2017 | Alcon Research, Ltd. LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope.
LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Terminated |
HRM | None listed |
| Aug 21, 2015 | Alcon Research, Ltd. LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue.
Product Usage:
The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Terminated |
HRM | None listed |
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