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MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO

K052660 Class II Traditional
Decision Date
2005-10-17
Sponsor / Applicant
The Richmond Light Co.

Technical Specification

510(k) Submission ID K052660
Product Code FTC
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4630
Decision Date 2005-10-17
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO received FDA 510(k) clearance under submission number K052660, sponsored by The Richmond Light Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2005-10-17.

Classification & Regulation

This clearance is catalogued under FDA product code FTC and 21 CFR 878.4630, within the General, Plastic Surgery review panel as a Class II device.