510(k) K111493
K111493 is an FDA 510(k) premarket notification submitted by Nidek Co., Ltd. for the device "NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI". The FDA issued a decision of Substantially Equivalent on July 27, 2011. The device falls under product code HQB (Photocoagulator And Accessories), a Class II device regulated under 21 CFR 886.4690. Nidek Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2011
- Date Received
- May 31, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photocoagulator And Accessories
- Device Class
- Class II
- Regulation Number
- 886.4690
- Review Panel
- OP
- Submission Type