CORNEAL LIGHT SHIELD
FDA 510(k) clearance K850270 · decided 1985-05-31
Clearance details
- K-number
- K850270
- Device name
- CORNEAL LIGHT SHIELD
- Applicant
- Mentor O & O, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-23
- Decision date
- 1985-05-31
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- HRM
- Device class
- 1
- Regulation number
- 878.4700
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hingham, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mentor O & O
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HM-0970 (K932720) | Hill-Med, Inc. | 1993-09-07 |
| MARCO SURGISCOPE OPERATION MICROSCOPES (K930439) | Marco Ophthalmic, Inc. | 1993-07-22 |
| ALCON OPERATING MICROSCOPES (K920641) | Alcon Laboratories | 1992-10-09 |
| KEELER KONAN SPECULAR MICROSCOPE SP5500 (K914956) | Keeler Instruments, Inc. | 1992-02-03 |
| S 22 INSTRUMENT STAND (K891584) | Carl Zeiss, Inc. | 1989-06-08 |
| MICROSCOPE KNOB COVER, STERILE, DISPOSABLE (K891001) | Prescott'S, Inc. | 1989-04-11 |
| MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 (K854440) | Keeler Instruments, Inc. | 1985-12-16 |
| XTAL X-150 OPERATING MICROSCOPE (K853855) | Xtal Corp. | 1985-10-15 |
| CROMIC SURGICAL MICROSCOPE MODEL MC-1 (K852586) | Seltrex, Corp. | 1985-07-30 |
| CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 (K852150) | Keeler Instruments, Inc. | 1985-06-03 |
| KONAN CLINIC MICROSCOPE CLM-100-150 (K844323) | Keeler Instruments, Inc. | 1984-11-21 |
| OPHTHALMIC MICROSCOPE (K822563) | Treace Medical, Inc. | 1982-09-14 |
Recalls involving this device
No recalls on record reference this clearance.