510(k) K152688
K152688 is an FDA 510(k) premarket notification submitted by Lightmed Corporation for the device "LightLas Multi-Wavelength Medical Laser System". The FDA issued a decision of Substantially Equivalent on Jun 15, 2016. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 15, 2016
- Date Received
- Sep 18, 2015
- 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)