Clearance Summary
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES received FDA 510(k) clearance under submission number K000457, sponsored by Retinalabs.Com. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2000-05-09.
- Submission: K000457
- Applicant / Sponsor: Retinalabs.Com
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 2000-05-09
Classification & Regulation
This clearance is catalogued under FDA product code HMX and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.