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FDA 510(k)

STARLITE 2006

K-Number: K052604 · 2005-12-16

ApplicantLaser Dental Innovations
Decision Date2005-12-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STARLITE 2006 is the device name listed in this FDA 510(k) record. The listed applicant is Laser Dental Innovations. It received FDA 510(k) clearance on 2005-12-16 under 510(k) number K052604. 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 STARLITE 2006?

STARLITE 2006 is a medical device that received FDA 510(k) clearance on 2005-12-16. The listed applicant is Laser Dental Innovations. The 510(k) number is K052604.

When did STARLITE 2006 receive FDA 510(k) clearance?

STARLITE 2006 received FDA 510(k) clearance on 2005-12-16, under 510(k) number K052604.

Who is the listed applicant for STARLITE 2006?

The FDA 510(k) record lists Laser Dental Innovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STARLITE 2006?

The FDA product code for STARLITE 2006 is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Laser Dental Innovations 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.

K993942LITESABER 2000

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

View on FDA Database →

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

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