510(k) K091981
K091981 is an FDA 510(k) premarket notification submitted by Lightmed Corp. for the device "LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER". The FDA issued a decision of Substantially Equivalent on Sep 28, 2009. 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 28, 2009
- Date Received
- Jul 1, 2009
- 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)