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)

DERMA K LASER SYSTEM

K-Number: K972872 · 1997-10-28

ApplicantEsc Medical Systems , Ltd.
Decision Date1997-10-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMA K LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Esc Medical Systems , Ltd.. It received FDA 510(k) clearance on 1997-10-28 under 510(k) number K972872. 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 DERMA K LASER SYSTEM?

DERMA K LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-28. The listed applicant is Esc Medical Systems , Ltd.. The 510(k) number is K972872.

When did DERMA K LASER SYSTEM receive FDA 510(k) clearance?

DERMA K LASER SYSTEM received FDA 510(k) clearance on 1997-10-28, under 510(k) number K972872.

Who is the listed applicant for DERMA K LASER SYSTEM?

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

What is the FDA product code for DERMA K LASER SYSTEM?

The FDA product code for DERMA K LASER SYSTEM 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 Esc Medical Systems , 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.

K994014ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHTK991935EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEMK982119DIODE LASERK974536PHOTODERM HR SYSTEMK980537ND: YAG ACCESSORY FOR PHOTODERM SYSTEMK972028DERMASCAN SURGICAL LASER SCANNER

View all 10 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.

↑