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)

SOFTLASE PRO, ORTHOLASE AND HYGIENELASE

K-Number: K091796 · 2009-07-31

ApplicantZap Lasers, LLC
Decision Date2009-07-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOFTLASE PRO, ORTHOLASE AND HYGIENELASE is the device name listed in this FDA 510(k) record. The listed applicant is Zap Lasers, LLC. It received FDA 510(k) clearance on 2009-07-31 under 510(k) number K091796. 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 SOFTLASE PRO, ORTHOLASE AND HYGIENELASE?

SOFTLASE PRO, ORTHOLASE AND HYGIENELASE is a medical device that received FDA 510(k) clearance on 2009-07-31. The listed applicant is Zap Lasers, LLC. The 510(k) number is K091796.

When did SOFTLASE PRO, ORTHOLASE AND HYGIENELASE receive FDA 510(k) clearance?

SOFTLASE PRO, ORTHOLASE AND HYGIENELASE received FDA 510(k) clearance on 2009-07-31, under 510(k) number K091796.

Who is the listed applicant for SOFTLASE PRO, ORTHOLASE AND HYGIENELASE?

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

What is the FDA product code for SOFTLASE PRO, ORTHOLASE AND HYGIENELASE?

The FDA product code for SOFTLASE PRO, ORTHOLASE AND HYGIENELASE 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 Zap Lasers, 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.

K081214STYLA MICROLASER AND STYLAORTHOK021227SOFTLASE G2-SURGICAL DIODE LASER SYSTEM

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.

↑