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FDA 510(k)

Cefaly

K-Number: K160237 · 2016-03-04

ApplicantCefaly Technology
Decision Date2016-03-04
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cefaly is a medical device manufactured by Cefaly Technology. It received FDA 510(k) clearance on 2016-03-04 under approval number K160237. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cefaly?

Cefaly is a medical device that received FDA 510(k) clearance on 2016-03-04. It is manufactured by Cefaly Technology. The 510(k) number is K160237.

When was Cefaly approved by the FDA?

Cefaly received FDA 510(k) clearance on 2016-03-04, under approval number K160237.

What company makes Cefaly?

Cefaly is manufactured by Cefaly Technology.

What is the FDA product code for Cefaly?

The FDA product code for Cefaly is PCC.

Other Devices by Cefaly Technology

K173006Cefaly Dual K171446Cefaly Acute K201895Cefaly Dual K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx K234029CEFALY Connected - OTC, CEFALY Connected - Rx

Related Devices (Code: PCC)

K173006Cefaly DualCefaly Technology K171446Cefaly AcuteCefaly Technology K172450TENS device-HeadaTerm, eEspressWat Medical Technology (Ningbo) Co., Ltd. K192773ALLIVENu Eyne Co., Ltd. K201895Cefaly DualCefaly Technology K212106RelivionNeurolief , 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.

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