VISION-STIMULATOR, CAM
FDA 510(k) clearance K781313 · decided 1979-01-26
Clearance details
- K-number
- K781313
- Device name
- VISION-STIMULATOR, CAM
- Applicant
- Clement Clarke, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-07-31
- Decision date
- 1979-01-26
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- HPL
- Device class
- 1
- Regulation number
- 886.1290
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY (K931731) | Storz Instrument Co. | 1994-08-29 |
| 360 DEGREE FIXATION LIGHT (K933739) | Varitronics | 1994-03-14 |
| ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) (K873914) | Richmond Products, Inc. | 1987-12-11 |
| KERATOLUX (K854383) | Carl Zeiss, Inc. | 1985-11-12 |
| FITE FIXATION TOY FOR OCULAR EXAM (K801381) | Fite Engineering Corp. | 1980-07-28 |
| AMBLYOPIA TRAINER (K800112) | Life-Tech Instruments, Inc. | 1980-03-10 |
Recalls involving this device
No recalls on record reference this clearance.