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)

0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE

K-Number: K870517 · 1987-04-10

ApplicantCoherent Medical Group
Decision Date1987-04-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Coherent Medical Group. It received FDA 510(k) clearance on 1987-04-10 under 510(k) number K870517. 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 for Some Indications.

Frequently Asked Questions

What is the 0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE?

0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE is a medical device that received FDA 510(k) clearance on 1987-04-10. The listed applicant is Coherent Medical Group. The 510(k) number is K870517.

When did 0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE receive FDA 510(k) clearance?

0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE received FDA 510(k) clearance on 1987-04-10, under 510(k) number K870517.

Who is the listed applicant for 0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE?

The FDA 510(k) record lists Coherent Medical Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE?

The FDA product code for 0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE 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 Coherent Medical Group 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.

K963339COHERENT ULTRAPULSE CO2 SURGICAL LASERSK960032COHERENT VERSAPULSE AESTHETIC SURGICAL LASERSK932981COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERSK923575COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERSK932468NOVUS MULTIWAVELENGTHK930981ACCULITE(TM) OTOPROBE

View all 27 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.

↑