Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NLITE SYSTEM,MODEL A00-1025

K-Number: K013461 · 2002-01-17

ApplicantIcn Photonics , Ltd.
Decision Date2002-01-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NLITE SYSTEM,MODEL A00-1025 is the device name listed in this FDA 510(k) record. The listed applicant is Icn Photonics , Ltd.. It received FDA 510(k) clearance on 2002-01-17 under 510(k) number K013461. 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 NLITE SYSTEM,MODEL A00-1025?

NLITE SYSTEM,MODEL A00-1025 is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Icn Photonics , Ltd.. The 510(k) number is K013461.

When did NLITE SYSTEM,MODEL A00-1025 receive FDA 510(k) clearance?

NLITE SYSTEM,MODEL A00-1025 received FDA 510(k) clearance on 2002-01-17, under 510(k) number K013461.

Who is the listed applicant for NLITE SYSTEM,MODEL A00-1025?

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

What is the FDA product code for NLITE SYSTEM,MODEL A00-1025?

The FDA product code for NLITE SYSTEM,MODEL A00-1025 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Icn Photonics , 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.

K024189NLITE SYSTEM, MODEL#: A00-1025/A00-1033K020729NLITE SYSTEM,MODEL A00-1051K014130NLITE 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

View on FDA Database →

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

↑