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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 the device name listed in this FDA 510(k) record. The listed applicant is Cefaly Technology. It received FDA 510(k) clearance on 2016-03-04 under 510(k) 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. The listed applicant is Cefaly Technology. The 510(k) number is K160237.

When did Cefaly receive FDA 510(k) clearance?

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

Who is the listed applicant for Cefaly?

The FDA 510(k) record lists Cefaly Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cefaly?

The FDA product code for Cefaly is PCC.

Other records listing Cefaly Technology as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234029CEFALY Connected - OTC, CEFALY Connected - RxK212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - RxK201895Cefaly DualK173006Cefaly DualK171446Cefaly Acute

Related Devices (Code: PCC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254216Enso for MigraineHinge Health, Inc.K242719ELEXIR 2.0 (ALLIVE3)Nu Eyne Co., Ltd.K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly TechnologyK232749DOOPANGYbrain, Inc.K233751Milieve (YPS-301BD)Soterix Medical, Inc.K230782TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc.

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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