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FDA 510(k)

The Time Machine Series Lasers

K-Number: K152461 · 2016-07-08

ApplicantMedical Lasers Manufacturer, Inc.
Decision Date2016-07-08
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

The Time Machine Series Lasers is the device name listed in this FDA 510(k) record. The listed applicant is Medical Lasers Manufacturer, Inc.. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K152461. 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 The Time Machine Series Lasers?

The Time Machine Series Lasers is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Medical Lasers Manufacturer, Inc.. The 510(k) number is K152461.

When did The Time Machine Series Lasers receive FDA 510(k) clearance?

The Time Machine Series Lasers received FDA 510(k) clearance on 2016-07-08, under 510(k) number K152461.

Who is the listed applicant for The Time Machine Series Lasers?

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

What is the FDA product code for The Time Machine Series Lasers?

The FDA product code for The Time Machine Series Lasers is ILY.

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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