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)

OPUS 10 DENTAL DIODE LASER

K-Number: K000990 · 2000-06-23

ApplicantOpusdent , Ltd.
Decision Date2000-06-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPUS 10 DENTAL DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Opusdent , Ltd.. It received FDA 510(k) clearance on 2000-06-23 under 510(k) number K000990. 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 OPUS 10 DENTAL DIODE LASER?

OPUS 10 DENTAL DIODE LASER is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Opusdent , Ltd.. The 510(k) number is K000990.

When did OPUS 10 DENTAL DIODE LASER receive FDA 510(k) clearance?

OPUS 10 DENTAL DIODE LASER received FDA 510(k) clearance on 2000-06-23, under 510(k) number K000990.

Who is the listed applicant for OPUS 10 DENTAL DIODE LASER?

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

What is the FDA product code for OPUS 10 DENTAL DIODE LASER?

The FDA product code for OPUS 10 DENTAL DIODE LASER 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 Opusdent , Ltd. 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.

K021508OPUSDUO EC DENTAL LASER SYSTEMK014100OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2NDK011769OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2NDK002899OPUS 20, MODEL 1ST

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.

↑