510(k) K861854
K861854 is an FDA 510(k) premarket notification submitted by Optek Medico Co., Ltd. for the device "OPM SLIT LAMP MODEL P-1". The FDA issued a decision of Substantially Equivalent on July 11, 1986. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Optek Medico Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1986
- Date Received
- May 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type