LENSTAR, MODEL LS900
FDA 510(k) clearance K082891 · decided 2009-10-20
Clearance details
- K-number
- K082891
- Device name
- LENSTAR, MODEL LS900
- Applicant
- Haag-Streit AG
- Decision
- Substantially Equivalent
- Date received
- 2008-09-30
- Decision date
- 2009-10-20
- Days to decision
- 385 days
- Clearance type
- Traditional
- Product code
- HJO
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Wadsworth, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers recall (Z-2964-2011) | Haag-Streit USA Inc | 2011-08-09 |
| Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland. Used fo recall (Z-1897-2010) | Haag-Streit USA Inc | 2010-06-24 |