The following data is part of a premarket notification filed by Haag-streit Ag with the FDA for Lenstar, Model Ls900.
| Device ID | K082891 |
| 510k Number | K082891 |
| Device Name: | LENSTAR, MODEL LS900 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | HAAG-STREIT AG 1667 RIDGEWOOD ROAD Wadsworth, OH 44281 |
| Contact | Lena Sattler |
| Correspondent | Lena Sattler HAAG-STREIT AG 1667 RIDGEWOOD ROAD Wadsworth, OH 44281 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2009-10-20 |
| Summary: | summary |