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FDA 510(k)

BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY

K-Number: K082876 · 2008-11-10

ApplicantSharplight Technologies, Ltd.
Decision Date2008-11-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Sharplight Technologies, Ltd.. It received FDA 510(k) clearance on 2008-11-10 under 510(k) number K082876. 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 BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY?

BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY is a medical device that received FDA 510(k) clearance on 2008-11-10. The listed applicant is Sharplight Technologies, Ltd.. The 510(k) number is K082876.

When did BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY receive FDA 510(k) clearance?

BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY received FDA 510(k) clearance on 2008-11-10, under 510(k) number K082876.

Who is the listed applicant for BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY?

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

What is the FDA product code for BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY?

The FDA product code for BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY is GEX. This falls under the Gastroenterology category.

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Other records listing Sharplight Technologies, 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.

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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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