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FDA 510(k)

CORELEADER SCAR-DIMMER

K-Number: K111733 · 2011-09-22

ApplicantCoreleader Biotech Co., Ltd.
Decision Date2011-09-22
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CORELEADER SCAR-DIMMER is the device name listed in this FDA 510(k) record. The listed applicant is Coreleader Biotech Co., Ltd.. It received FDA 510(k) clearance on 2011-09-22 under 510(k) number K111733. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORELEADER SCAR-DIMMER?

CORELEADER SCAR-DIMMER is a medical device that received FDA 510(k) clearance on 2011-09-22. The listed applicant is Coreleader Biotech Co., Ltd.. The 510(k) number is K111733.

When did CORELEADER SCAR-DIMMER receive FDA 510(k) clearance?

CORELEADER SCAR-DIMMER received FDA 510(k) clearance on 2011-09-22, under 510(k) number K111733.

Who is the listed applicant for CORELEADER SCAR-DIMMER?

The FDA 510(k) record lists Coreleader Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORELEADER SCAR-DIMMER?

The FDA product code for CORELEADER SCAR-DIMMER is MDA.

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Other records listing Coreleader Biotech Co., Ltd. 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.

K123394CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSINGK111578CORELEADER COLLA-ALGI FIBER MODEL CAWK102944CORELEADER HEMO-PAD MODEL CPII 02030K102942CORELEADER ALGIPLASTER MODEL AP 050501K102946CORELEADER COLLA-PAD MODEL CS 03030K102943CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050

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Related Devices (Code: MDA)

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.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson Medical, Inc.K024057CURAD SCAR THERAPYBeiersdorf, 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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