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FDA 510(k)

LUMACARE LC-122M NON-COHERENT LIGHT SOURCE

K-Number: K062871 · 2006-11-14

ApplicantLynton Lasers Limited
Decision Date2006-11-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUMACARE LC-122M NON-COHERENT LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Lynton Lasers Limited. It received FDA 510(k) clearance on 2006-11-14 under 510(k) number K062871. 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 LUMACARE LC-122M NON-COHERENT LIGHT SOURCE?

LUMACARE LC-122M NON-COHERENT LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 2006-11-14. The listed applicant is Lynton Lasers Limited. The 510(k) number is K062871.

When did LUMACARE LC-122M NON-COHERENT LIGHT SOURCE receive FDA 510(k) clearance?

LUMACARE LC-122M NON-COHERENT LIGHT SOURCE received FDA 510(k) clearance on 2006-11-14, under 510(k) number K062871.

Who is the listed applicant for LUMACARE LC-122M NON-COHERENT LIGHT SOURCE?

The FDA 510(k) record lists Lynton Lasers Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMACARE LC-122M NON-COHERENT LIGHT SOURCE?

The FDA product code for LUMACARE LC-122M NON-COHERENT LIGHT SOURCE is GEX. This falls under the Gastroenterology category.

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Other records listing Lynton Lasers Limited 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.

K072048LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBEK063427LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM

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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