510(k) K130195
K130195 is an FDA 510(k) premarket notification submitted by Lumenis, Inc. for the device "SCANNING LASERLINK". The FDA issued a decision of Substantially Equivalent on November 1, 2013. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Lumenis, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2013
- Date Received
- January 28, 2013
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type