K093639 is an FDA 510(k) clearance for the SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).
Submitted by Huvitz Co., Ltd. (Tempe, US). The FDA issued a Cleared decision on December 3, 2009, 9 days after receiving the submission on November 24, 2009.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K093639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2009 |
| Decision Date | December 03, 2009 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HJO - Biomicroscope, Slit-lamp, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |