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FDA 510(k)

DERMATOLOGICAL TREATMENT DEVICE FAMILY

K-Number: K111303 · 2011-12-21

ApplicantSharplight Technologies, Ltd.
Decision Date2011-12-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMATOLOGICAL TREATMENT 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 2011-12-21 under 510(k) number K111303. 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 DERMATOLOGICAL TREATMENT DEVICE FAMILY?

DERMATOLOGICAL TREATMENT DEVICE FAMILY is a medical device that received FDA 510(k) clearance on 2011-12-21. The listed applicant is Sharplight Technologies, Ltd.. The 510(k) number is K111303.

When did DERMATOLOGICAL TREATMENT DEVICE FAMILY receive FDA 510(k) clearance?

DERMATOLOGICAL TREATMENT DEVICE FAMILY received FDA 510(k) clearance on 2011-12-21, under 510(k) number K111303.

Who is the listed applicant for DERMATOLOGICAL TREATMENT 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 DERMATOLOGICAL TREATMENT DEVICE FAMILY?

The FDA product code for DERMATOLOGICAL TREATMENT 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.

K233304Omnimax S3, Omnimax S4K173169Rapid FamilyK082876BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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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