LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER
FDA 510(k) clearance K864369 · decided 1986-12-15
Clearance details
- K-number
- K864369
- Device name
- LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER
- Applicant
- Heidelberg Instruments
- Decision
- Substantially Equivalent
- Date received
- 1986-11-05
- Decision date
- 1986-12-15
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- HJB
- Device class
- 1
- Regulation number
- 886.1450
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- La Jolla, CA, 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 |
|---|---|---|
| MARCO STANDARD KERATOMETERS (K930444) | Marco Ophthalmic, Inc. | 1993-08-09 |
| BURTON KERATOMETER - MODLE 2040 (K924779) | R.H. Burton Co. | 1993-04-05 |
| KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER (K864037) | Kera Corp. | 1986-11-13 |
| ACUFEX COMPARATIVE SURGICAL KERATOMETER (K852424) | Acufex Microsurgical, Inc. | 1985-09-11 |
Recalls involving this device
No recalls on record reference this clearance.