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FDA 510(k)

MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS

K-Number: K050950 · 2005-04-29

ApplicantActive Optical Systems, Ltd./Efraim Bidas
Decision Date2005-04-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Active Optical Systems, Ltd./Efraim Bidas. It received FDA 510(k) clearance on 2005-04-29 under 510(k) number K050950. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS?

MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS is a medical device that received FDA 510(k) clearance on 2005-04-29. The listed applicant is Active Optical Systems, Ltd./Efraim Bidas. The 510(k) number is K050950.

When did MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS receive FDA 510(k) clearance?

MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS received FDA 510(k) clearance on 2005-04-29, under 510(k) number K050950.

Who is the listed applicant for MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS?

The FDA 510(k) record lists Active Optical Systems, Ltd./Efraim Bidas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS?

The FDA product code for MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS is GEX. This falls under the Gastroenterology category.

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Official Source

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