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FDA 510(k)

ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC

K-Number: K083915 · 2009-01-29

ApplicantAdvanced Technology Laser Co., Ltd.
Decision Date2009-01-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laser Co., Ltd.. It received FDA 510(k) clearance on 2009-01-29 under 510(k) number K083915. 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 ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC?

ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC is a medical device that received FDA 510(k) clearance on 2009-01-29. The listed applicant is Advanced Technology Laser Co., Ltd.. The 510(k) number is K083915.

When did ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC receive FDA 510(k) clearance?

ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC received FDA 510(k) clearance on 2009-01-29, under 510(k) number K083915.

Who is the listed applicant for ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC?

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

What is the FDA product code for ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC?

The FDA product code for ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC is GEX. This falls under the Gastroenterology category.

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Other records listing Advanced Technology Laser Co., Ltd. as applicant

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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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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