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FDA 510(k)

K-LASER

K-Number: K120604 · 2012-05-25

ApplicantEltech S.R.L
Decision Date2012-05-25
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

K-LASER is the device name listed in this FDA 510(k) record. The listed applicant is Eltech S.R.L. It received FDA 510(k) clearance on 2012-05-25 under 510(k) number K120604. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-LASER?

K-LASER is a medical device that received FDA 510(k) clearance on 2012-05-25. The listed applicant is Eltech S.R.L. The 510(k) number is K120604.

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

K-LASER received FDA 510(k) clearance on 2012-05-25, under 510(k) number K120604.

Who is the listed applicant for K-LASER?

The FDA 510(k) record lists Eltech S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-LASER?

The FDA product code for K-LASER is ILY.

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 Eltech S.R.L 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.

K091497K-LASER K-1200, MODEL 12 WK050070K-LASER, MODELS 3,4,4D,6D

Related Devices (Code: ILY)

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.

K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd.K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company , Ltd.K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc.K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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