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)

CONBIO MEDALEX LASER SYSTEM

K-Number: K935631 · 1994-08-23

ApplicantContinuum Biomedical, Inc.
Decision Date1994-08-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONBIO MEDALEX LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Continuum Biomedical, Inc.. It received FDA 510(k) clearance on 1994-08-23 under 510(k) number K935631. 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 CONBIO MEDALEX LASER SYSTEM?

CONBIO MEDALEX LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-08-23. The listed applicant is Continuum Biomedical, Inc.. The 510(k) number is K935631.

When did CONBIO MEDALEX LASER SYSTEM receive FDA 510(k) clearance?

CONBIO MEDALEX LASER SYSTEM received FDA 510(k) clearance on 1994-08-23, under 510(k) number K935631.

Who is the listed applicant for CONBIO MEDALEX LASER SYSTEM?

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

What is the FDA product code for CONBIO MEDALEX LASER SYSTEM?

The FDA product code for CONBIO MEDALEX LASER SYSTEM 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 Continuum Biomedical, 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.

K992013DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASERK983054MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASERK973719MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASERK970808MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASERK971903SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASERK971879SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER

View all 19 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.

↑