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)

CURVED ENDOPHOTOCOAGULATOR LASER PROBE

K-Number: K944470 · 1994-11-03

ApplicantMnlase, Inc.
Decision Date1994-11-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CURVED ENDOPHOTOCOAGULATOR LASER PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Mnlase, Inc.. It received FDA 510(k) clearance on 1994-11-03 under 510(k) number K944470. 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 CURVED ENDOPHOTOCOAGULATOR LASER PROBE?

CURVED ENDOPHOTOCOAGULATOR LASER PROBE is a medical device that received FDA 510(k) clearance on 1994-11-03. The listed applicant is Mnlase, Inc.. The 510(k) number is K944470.

When did CURVED ENDOPHOTOCOAGULATOR LASER PROBE receive FDA 510(k) clearance?

CURVED ENDOPHOTOCOAGULATOR LASER PROBE received FDA 510(k) clearance on 1994-11-03, under 510(k) number K944470.

Who is the listed applicant for CURVED ENDOPHOTOCOAGULATOR LASER PROBE?

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

What is the FDA product code for CURVED ENDOPHOTOCOAGULATOR LASER PROBE?

The FDA product code for CURVED ENDOPHOTOCOAGULATOR LASER PROBE 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 Mnlase, 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.

K944630MODEL 230-SAS LASER DELIVERY PROBEK944629MODEL 230-SAC LASER DELIVERY PROBEK944628MODEL 220-SS LASER DELIVERY PROBEK944471STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBEK944625MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASERK944627MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER

View all 22 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.

↑