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FDA 510(k)

COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT

K-Number: K041679 · 2004-12-16

ApplicantOnyx Medical, Inc.
Decision Date2004-12-16
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Onyx Medical, Inc.. It received FDA 510(k) clearance on 2004-12-16 under 510(k) number K041679. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT?

COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT is a medical device that received FDA 510(k) clearance on 2004-12-16. The listed applicant is Onyx Medical, Inc.. The 510(k) number is K041679.

When did COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT receive FDA 510(k) clearance?

COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT received FDA 510(k) clearance on 2004-12-16, under 510(k) number K041679.

Who is the listed applicant for COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT?

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

What is the FDA product code for COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT?

The FDA product code for COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT is ILY.

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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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