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FDA 510(k)

C100 WRINKLE REDUCTION DEVICE

K-Number: K112362 · 2012-08-14

ApplicantSilver Bay, LLC
Decision Date2012-08-14
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

C100 WRINKLE REDUCTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Silver Bay, LLC. It received FDA 510(k) clearance on 2012-08-14 under 510(k) number K112362. 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 C100 WRINKLE REDUCTION DEVICE?

C100 WRINKLE REDUCTION DEVICE is a medical device that received FDA 510(k) clearance on 2012-08-14. The listed applicant is Silver Bay, LLC. The 510(k) number is K112362.

When did C100 WRINKLE REDUCTION DEVICE receive FDA 510(k) clearance?

C100 WRINKLE REDUCTION DEVICE received FDA 510(k) clearance on 2012-08-14, under 510(k) number K112362.

Who is the listed applicant for C100 WRINKLE REDUCTION DEVICE?

The FDA 510(k) record lists Silver Bay, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C100 WRINKLE REDUCTION DEVICE?

The FDA product code for C100 WRINKLE REDUCTION DEVICE is OHS.

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Other records listing Silver Bay, LLC 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.

K111286QUASAR CALYPSOK091467BABY QUASARK093963QUASAR BLUE LIGHT THERAPY SYSTEMK072767QUASAR BLUE LIGHT THERAPY SYSTEM

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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