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FDA 510(k)

KELOCOTE SCAR GEL AND KELOCOTE LASER GEL

K-Number: K973572 · 1997-10-21

ApplicantHanson Medical, Inc.
Decision Date1997-10-21
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KELOCOTE SCAR GEL AND KELOCOTE LASER GEL is the device name listed in this FDA 510(k) record. The listed applicant is Hanson Medical, Inc.. It received FDA 510(k) clearance on 1997-10-21 under 510(k) number K973572. 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 KELOCOTE SCAR GEL AND KELOCOTE LASER GEL?

KELOCOTE SCAR GEL AND KELOCOTE LASER GEL is a medical device that received FDA 510(k) clearance on 1997-10-21. The listed applicant is Hanson Medical, Inc.. The 510(k) number is K973572.

When did KELOCOTE SCAR GEL AND KELOCOTE LASER GEL receive FDA 510(k) clearance?

KELOCOTE SCAR GEL AND KELOCOTE LASER GEL received FDA 510(k) clearance on 1997-10-21, under 510(k) number K973572.

Who is the listed applicant for KELOCOTE SCAR GEL AND KELOCOTE LASER GEL?

The FDA 510(k) record lists Hanson Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KELOCOTE SCAR GEL AND KELOCOTE LASER GEL?

The FDA product code for KELOCOTE SCAR GEL AND KELOCOTE LASER GEL is MDA.

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Other records listing Hanson Medical, Inc. 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.

K090803HANSON MEDICAL FACIAL IMPLANTSK071018MONARCH NASAL IMPLANTK041690MONARCH NASAL IMPLANTK040307HANSON SCAR ADEK030808HANSON MEDICAL CALF IMPLANTK030809HANSON MEDICAL GLUTEAL IMPLANT

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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.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.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.

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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