Clearance Summary
GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE received FDA 510(k) clearance under submission number K954306, sponsored by Gamp & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-12-22.
- Submission: K954306
- Applicant / Sponsor: Gamp & Assoc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4690
- Decision date: 1995-12-22
Classification & Regulation
This clearance is catalogued under FDA product code HQB and 21 CFR 886.4690, within the Ophthalmic review panel as a Class II device.