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)

MEGABEAM

K-Number: K923953 · 1992-11-17

ApplicantCeram Optec, Inc.
Decision Date1992-11-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEGABEAM is the device name listed in this FDA 510(k) record. The listed applicant is Ceram Optec, Inc.. It received FDA 510(k) clearance on 1992-11-17 under 510(k) number K923953. 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 MEGABEAM?

MEGABEAM is a medical device that received FDA 510(k) clearance on 1992-11-17. The listed applicant is Ceram Optec, Inc.. The 510(k) number is K923953.

When did MEGABEAM receive FDA 510(k) clearance?

MEGABEAM received FDA 510(k) clearance on 1992-11-17, under 510(k) number K923953.

Who is the listed applicant for MEGABEAM?

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

What is the FDA product code for MEGABEAM?

The FDA product code for MEGABEAM 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 Ceram Optec, 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.

K002296CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15K001975CERALAS D10 810NM LASER, MODEL CERALAS D10-60K993911CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50K993828CERALAS D10 810NM DIODE LASERK993002CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15K992773CERALAS D10 810NM DIODE LASER

View all 30 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.

↑