KERATOLUX
FDA 510(k) clearance K854383 · decided 1985-11-12
Clearance details
- K-number
- K854383
- Device name
- KERATOLUX
- Applicant
- Carl Zeiss, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-30
- Decision date
- 1985-11-12
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- HPL
- Device class
- 1
- Regulation number
- 886.1290
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Thornwood, NY, 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 |
| FITE FIXATION TOY FOR OCULAR EXAM (K801381) | Fite Engineering Corp. | 1980-07-28 |
| AMBLYOPIA TRAINER (K800112) | Life-Tech Instruments, Inc. | 1980-03-10 |
| VISION-STIMULATOR, CAM (K781313) | Clement Clarke, Inc. | 1979-01-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS ND:YAG LASER (P850083/S008) | Carl Zeiss, Inc. | 1989-08-02 |
| VISULAS ND:YAG LASER (P850083/S007) | Carl Zeiss, Inc. | 1988-07-15 |
| VISULAS ND:YAG LASER (P850083/S006) | Carl Zeiss, Inc. | 1987-10-05 |
| VISULAS ND:YAG LASER (P850083/S005) | Carl Zeiss, Inc. | 1987-09-30 |
| VISULAS ND:YAG LASER (P850083/S004) | Carl Zeiss, Inc. | 1987-03-31 |
| VISULAS ND:YAG LASER (P850083/S001) | Carl Zeiss, Inc. | 1987-03-10 |
| VISULAS ND:YAG LASER (P850083/S003) | Carl Zeiss, Inc. | 1986-12-04 |