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FDA 510(k)

FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR

K-Number: K101510 · 2011-02-17

ApplicantEndymed Medical, Ltd.
Decision Date2011-02-17
Product CodeOUH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Endymed Medical, Ltd.. It received FDA 510(k) clearance on 2011-02-17 under 510(k) number K101510. The device is classified under product code OUH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR?

FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR is a medical device that received FDA 510(k) clearance on 2011-02-17. The listed applicant is Endymed Medical, Ltd.. The 510(k) number is K101510.

When did FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR receive FDA 510(k) clearance?

FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR received FDA 510(k) clearance on 2011-02-17, under 510(k) number K101510.

Who is the listed applicant for FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR?

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

What is the FDA product code for FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR?

The FDA product code for FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR is OUH.

Related Clinical Trials

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Other records listing Endymed Medical, 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.

K242996EndyMed PRO MAXK222369PURE LaserK161715EndyGelK161199EndyMed Contour HandpieceK120513GLOW BY ENDYMED

Related Devices (Code: OUH)

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.

K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,LtdK120513GLOW BY ENDYMEDEndymed Medical, Ltd.

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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