510(k) K892058
K892058 is an FDA 510(k) premarket notification submitted by Intelligent Surgical Lasers, Inc. for the device "ISL QC 2000". The FDA issued a decision of Substantially Equivalent on June 15, 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. Intelligent Surgical Lasers, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 1989
- Date Received
- March 29, 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