Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
FDA product code HRM · Class I (low risk) · 21 CFR 878.4700 · General, Plastic Surgery
14510(k) clearances
0PMA approvals
7recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932720 | HM-0970HRM · Traditional | Hill-Med, Inc. | 09/07/1993SE |
| K930439 | Marco Surgiscope Operation MicroscopesHRM · Traditional | Marco Ophthalmic, Inc. | 07/22/1993SE |
| K920641 | Alcon Operating MicroscopesHRM · Traditional | Alcon Laboratories | 10/09/1992SE |
| K914956 | Keeler Konan Specular Microscope SP5500HRM · Traditional | Keeler Instruments, Inc. | 02/03/1992SE |
| K891584 | S 22 Instrument StandHRM · Traditional | Carl Zeiss, Inc. | 06/08/1989SE |
| K891001 | Microscope Knob Cover, Sterile, DisposableHRM · Traditional | Prescott'S, Inc. | 04/11/1989SE |
| K854440 | Modified Clinical Widefield Specular Microscope 50HRM · Traditional | Keeler Instruments, Inc. | 12/16/1985SE |
| K853855 | Xtal X-150 Operating MicroscopeHRM · Traditional | Xtal Corp. | 10/15/1985SE |
| K852586 | Cromic Surgical Microscope Model MC-1HRM · Traditional | Seltrex, Corp. | 07/30/1985SE |
| K852150 | Clinical Widefield Specular Micriscope 500HRM · Traditional | Keeler Instruments, Inc. | 06/03/1985SE |
| K850270 | Corneal Light ShieldHRM · Traditional | Mentor O & O, Inc. | 05/31/1985SE |
| K844323 | Konan Clinic Microscope CLM-100-150HRM · Traditional | Keeler Instruments, Inc. | 11/21/1984SE |
| K822563 | Ophthalmic MicroscopeHRM · Traditional | Treace Medical, Inc. | 09/14/1982SE |
| K792083 | Haag-Streit Slit Lamp 900HRM · Traditional | Lumenis, Inc. | 11/16/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0475-2023 Class II | Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope systemThere is a potential issue resulting in the Power Supply potentially becoming overheated due to internal… | Leica Microsystems, Inc. | 11/21/2022Open, Classified |
| Z-0697-2021 Class II | Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no.…Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing… | Haag-Streit USA Inc | 11/20/2020Open, Classified |
| Z-0772-2019 Class II | Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical…The M220 optics may unintentionally drop into the surgical field, risking contact with the patient. | Leica Microsystems, Inc. | 01/02/2019Terminated |
| Z-0961-2019 Class II | Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification…Potential for the optical head to detach from the stand due to the lack of thread adhesive. | Alcon Research Laboratories Ltd. | 07/17/2018Terminated |
| Z-0838-2019 Class II | PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of…The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement… | Leica Microsystems, Inc. | 09/25/2017Terminated |
| Z-3081-2017 Class II | LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic…Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base… | Alcon Research, Ltd. | 05/25/2017Terminated |
| Z-2448-2015 Class II | LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product…Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning… | Alcon Research, Ltd. | 08/11/2015Terminated |