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FDA 510(k)

K-LASER K-1200, MODEL 12 W

K-Number: K091497 · 2009-08-19

ApplicantEltech S.R.L
Decision Date2009-08-19
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

K-LASER K-1200, MODEL 12 W 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 2009-08-19 under 510(k) number K091497. 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-1200, MODEL 12 W?

K-LASER K-1200, MODEL 12 W is a medical device that received FDA 510(k) clearance on 2009-08-19. The listed applicant is Eltech S.R.L. The 510(k) number is K091497.

When did K-LASER K-1200, MODEL 12 W receive FDA 510(k) clearance?

K-LASER K-1200, MODEL 12 W received FDA 510(k) clearance on 2009-08-19, under 510(k) number K091497.

Who is the listed applicant for K-LASER K-1200, MODEL 12 W?

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 K-1200, MODEL 12 W?

The FDA product code for K-LASER K-1200, MODEL 12 W is ILY.

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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.

K120604K-LASERK050070K-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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