510(k) K893987
K893987 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "NIDEK MODEL YC-1200". The FDA issued a decision of Substantially Equivalent on August 18, 1989. The device falls under product code LXS (Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla), a Class II device regulated under 21 CFR 886.4392. Nidek, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1989
- Date Received
- June 5, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
- Device Class
- Class II
- Regulation Number
- 886.4392
- Review Panel
- OP
- Submission Type