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FDA 510(k)

VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100

K-Number: K051259 · 2005-09-20

ApplicantTheralight, Inc.
Decision Date2005-09-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Theralight, Inc.. It received FDA 510(k) clearance on 2005-09-20 under 510(k) number K051259. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100?

VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 is a medical device that received FDA 510(k) clearance on 2005-09-20. The listed applicant is Theralight, Inc.. The 510(k) number is K051259.

When did VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 receive FDA 510(k) clearance?

VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 received FDA 510(k) clearance on 2005-09-20, under 510(k) number K051259.

Who is the listed applicant for VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100?

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

What is the FDA product code for VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100?

The FDA product code for VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 is GEX. This falls under the Gastroenterology category.

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Other records listing Theralight, 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.

K061295VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100K024020THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEMK022165THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2

Related Devices (Code: GEX)

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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