Corneal Light Shield
FDA 510(k) K850270 · Mentor O & O, Inc.
510(k) numberK850270
Submission
- Device name
- Corneal Light Shield
- Applicant
- Mentor O & O, Inc.
Hingham, MA, US - Received
- January 23, 1985
- Decision date
- May 31, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HRM – Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4700
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HRM
| 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 |
More from Keeler Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955245 | Mentor Meridian Phacoemulsification SystemHQC · Traditional | 02/12/1996SE |
| K934320 | Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion AspirationHQR · Traditional | 02/16/1994SE |
| K912904 | Mentor Odyssey Phacoemulsification SystemHQC · Traditional | 06/11/1992SE |
| K915340 | Mentor Horizon Low Vision MagnifierHJG · Traditional | 03/30/1992SE |
| K910637 | Mentor(R) Sur-E-Trol(R)FRN · Traditional | 05/13/1991SE |
| K911160 | Mentor(R) Wet-Field(R) II Ac Coagulator, 22-1305GEI · Traditional | 05/02/1991SE |
| K903878 | Mentor(R) Durastat(Tm) Autoclav Bipolar HemostatHQQ · Traditional | 11/05/1990SE |
| K895010 | Mentor Spectacle Binocular Indirect OphthalmoscopeHLI · Traditional | 09/11/1989SE |
| K890622 | Surg-E-Trol System I and System IIHQE · Traditional | 05/04/1989SE |
| K890595 | Mentor Anterior Segment VitrectorHKP · Traditional | 04/17/1989SE |
Questions and answers
When was Corneal Light Shield cleared by the FDA?
Corneal Light Shield (K850270) received a 510(k) decision of Substantially Equivalent on May 31, 1985, 128 days after the submission was received.
What is the product code of K850270?
The FDA product code is HRM – Microscope, Operating & Accessories, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 878.4700.