510(k) K093639
K093639 is an FDA 510(k) premarket notification submitted by Huvitz Co., Ltd. for the device "SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500". The FDA issued a decision of Substantially Equivalent on December 3, 2009. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Huvitz Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2009
- Date Received
- November 24, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type