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)

SAPPHIRE ST PORTABLE DIODE LASER

K-Number: K103667 · 2010-12-29

ApplicantDen-Mat Holdings, LLC
Decision Date2010-12-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAPPHIRE ST PORTABLE DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Holdings, LLC. It received FDA 510(k) clearance on 2010-12-29 under 510(k) number K103667. 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 SAPPHIRE ST PORTABLE DIODE LASER?

SAPPHIRE ST PORTABLE DIODE LASER is a medical device that received FDA 510(k) clearance on 2010-12-29. The listed applicant is Den-Mat Holdings, LLC. The 510(k) number is K103667.

When did SAPPHIRE ST PORTABLE DIODE LASER receive FDA 510(k) clearance?

SAPPHIRE ST PORTABLE DIODE LASER received FDA 510(k) clearance on 2010-12-29, under 510(k) number K103667.

Who is the listed applicant for SAPPHIRE ST PORTABLE DIODE LASER?

The FDA 510(k) record lists Den-Mat Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAPPHIRE ST PORTABLE DIODE LASER?

The FDA product code for SAPPHIRE ST PORTABLE 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 Den-Mat Holdings, LLC 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.

K262252MPa Max adhesiveK242097DenMat Bulk Fill CompositeK162967nuance UNIVERSALK110079SPPHINE PLUS STM 3W DIODE LASERK081287SAPPHIRE PLASMA ARC DENTAL CURING LIGHTK073483SAPPHIRE O/E ORAL EXAMINATION SYSTEM

View all 7 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.

↑