510(k) K063297
K063297 is an FDA 510(k) premarket notification submitted by Lightmed Corp. for the device "LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR". The FDA issued a decision of Substantially Equivalent on Sep 20, 2007. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Lightmed Corp. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 20, 2007
- Date Received
- Nov 1, 2006
- Clearance Type
- Traditional
- 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
- 510(k)