510(k) K901605
K901605 is an FDA 510(k) premarket notification submitted by Phoenix Laser Systems, Inc. for the device "PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.". The FDA issued a decision of Substantially Equivalent on December 13, 1990. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1990
- Date Received
- April 5, 1990
- 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