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FDA 510(k)

Carewear Firefly Wrinkle Reduction

K-Number: K202442 · 2020-11-19

ApplicantCarewear Corp.
Decision Date2020-11-19
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Carewear Firefly Wrinkle Reduction is the device name listed in this FDA 510(k) record. The listed applicant is Carewear Corp.. It received FDA 510(k) clearance on 2020-11-19 under 510(k) number K202442. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Carewear Firefly Wrinkle Reduction?

Carewear Firefly Wrinkle Reduction is a medical device that received FDA 510(k) clearance on 2020-11-19. The listed applicant is Carewear Corp.. The 510(k) number is K202442.

When did Carewear Firefly Wrinkle Reduction receive FDA 510(k) clearance?

Carewear Firefly Wrinkle Reduction received FDA 510(k) clearance on 2020-11-19, under 510(k) number K202442.

Who is the listed applicant for Carewear Firefly Wrinkle Reduction?

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

What is the FDA product code for Carewear Firefly Wrinkle Reduction?

The FDA product code for Carewear Firefly Wrinkle Reduction is OHS.

Related Devices (Code: OHS)

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.

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Official Source

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

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