Clearance Summary
NEUROLASE, MODELS 150V, 150C, 1064 received FDA 510(k) clearance under submission number K032787, sponsored by Spectrum Laser & Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2003-11-20.
- Submission: K032787
- Applicant / Sponsor: Spectrum Laser & Technologies
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2003-11-20
Classification & Regulation
This clearance is catalogued under FDA product code ILY and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.