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STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS

K100702 Class II Traditional
Decision Date
2010-07-20
Sponsor / Applicant
Huot Instruments, LLC

Technical Specification

510(k) Submission ID K100702
Product Code FSY
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4580
Decision Date 2010-07-20
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS received FDA 510(k) clearance under submission number K100702, sponsored by Huot Instruments, LLC. 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 2010-07-20.

Classification & Regulation

This clearance is catalogued under FDA product code FSY and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.