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)

MULTILASE 60

K-Number: K904229 · 1990-12-12

ApplicantLaser Photonics, Inc.
Decision Date1990-12-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTILASE 60 is the device name listed in this FDA 510(k) record. The listed applicant is Laser Photonics, Inc.. It received FDA 510(k) clearance on 1990-12-12 under 510(k) number K904229. 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 MULTILASE 60?

MULTILASE 60 is a medical device that received FDA 510(k) clearance on 1990-12-12. The listed applicant is Laser Photonics, Inc.. The 510(k) number is K904229.

When did MULTILASE 60 receive FDA 510(k) clearance?

MULTILASE 60 received FDA 510(k) clearance on 1990-12-12, under 510(k) number K904229.

Who is the listed applicant for MULTILASE 60?

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

What is the FDA product code for MULTILASE 60?

The FDA product code for MULTILASE 60 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 Laser Photonics, 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.

K934501LASER PHOTONICS ML755 DERMABLASERK933140RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEMK924537LPI ML210 HOLMIUM SURGICAL LASERK920334LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH.K915631LPI ML 100/532 AND ML 532 SURGICAL LASERK914827LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION

View all 14 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.

↑