FDA 510(k)

SKIN CARE

K-Number: K152736 · 2016-02-25

Decision Date2016-02-25

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SKIN CARE is a medical device manufactured by C.I.S, Ltd.. It received FDA 510(k) clearance on 2016-02-25 under approval number K152736. 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 SKIN CARE?

SKIN CARE is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by C.I.S, Ltd.. The 510(k) number is K152736.

When was SKIN CARE approved by the FDA?

SKIN CARE received FDA 510(k) clearance on 2016-02-25, under approval number K152736.

What company makes SKIN CARE?

SKIN CARE is manufactured by C.I.S, Ltd..

What is the FDA product code for SKIN CARE?

The FDA product code for SKIN CARE is GEX. This falls under the Gastroenterology category.

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.