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)

LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980

K-Number: K040294 · 2004-05-05

ApplicantPhoto Medex, Inc.
Decision Date2004-05-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 is the device name listed in this FDA 510(k) record. The listed applicant is Photo Medex, Inc.. It received FDA 510(k) clearance on 2004-05-05 under 510(k) number K040294. 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 LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980?

LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 is a medical device that received FDA 510(k) clearance on 2004-05-05. The listed applicant is Photo Medex, Inc.. The 510(k) number is K040294.

When did LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 receive FDA 510(k) clearance?

LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 received FDA 510(k) clearance on 2004-05-05, under 510(k) number K040294.

Who is the listed applicant for LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980?

The FDA 510(k) record lists Photo Medex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980?

The FDA product code for LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 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 Photo Medex, Inc. 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.

K082721LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMSK073659XTRAC ULTRA 2, MODEL AL10000K051428VTRAC EXCIMER LAMP SYSTEMK041943XTRAC XL, MODEL AL8000K040234LASERPRO CO2 CARBON DIOXIDE LASER SYSTEMK031451XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000

View all 10 devices →

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.

↑