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)

SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER

K-Number: K960820 · 1996-05-10

ApplicantSharplan Lasers, Inc.
Decision Date1996-05-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Sharplan Lasers, Inc.. It received FDA 510(k) clearance on 1996-05-10 under 510(k) number K960820. 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 SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER?

SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER is a medical device that received FDA 510(k) clearance on 1996-05-10. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K960820.

When did SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER receive FDA 510(k) clearance?

SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER received FDA 510(k) clearance on 1996-05-10, under 510(k) number K960820.

Who is the listed applicant for SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER?

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

What is the FDA product code for SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER?

The FDA product code for SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER 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 Sharplan Lasers, 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.

K973354SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K972099SHARPLAN EPITOUCH RUBY LASER SYSTEMK971874SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K971648SHARPLAN ERBIUM: YAG LASER (4020)K971743SHARPLAN CO2 SURGICAL LASER SYSTEMK962446SHARPLAN RUBY LASER SYSTEM

View all 78 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.

↑