The following data is part of a premarket notification filed by Heidelberg Instruments with the FDA for Lts Corneal Microscope Laser Tomographic Scanner.
| Device ID | K864369 |
| 510k Number | K864369 |
| Device Name: | LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER |
| Classification | Instrument, Measuring, Corneal Radius |
| Applicant | HEIDELBERG INSTRUMENTS UNIV. OF CALIFORNIA, SAN DIEGO DEPT. OF OPHTHALMOLOGY (T-014) La Jolla, CA 92093 |
| Contact | Stuart I Brown |
| Correspondent | Stuart I Brown HEIDELBERG INSTRUMENTS UNIV. OF CALIFORNIA, SAN DIEGO DEPT. OF OPHTHALMOLOGY (T-014) La Jolla, CA 92093 |
| Product Code | HJB |
| CFR Regulation Number | 886.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-05 |
| Decision Date | 1986-12-15 |