Clearance Summary
LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE received FDA 510(k) clearance under submission number K880591, sponsored by Laser Peripherals, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1988-06-01.
- Submission: K880591
- Applicant / Sponsor: Laser Peripherals, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4550
- Decision date: 1988-06-01
Classification & Regulation
This clearance is catalogued under FDA product code HHR and 21 CFR 884.4550, within the Obstetrics/Gynecology review panel as a Class II device.