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FDA 510(k)

MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER

K-Number: K082707 · 2008-10-01

ApplicantMedx Electronics, Inc.
Decision Date2008-10-01
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Medx Electronics, Inc.. It received FDA 510(k) clearance on 2008-10-01 under 510(k) number K082707. 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 MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER?

MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER is a medical device that received FDA 510(k) clearance on 2008-10-01. The listed applicant is Medx Electronics, Inc.. The 510(k) number is K082707.

When did MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER receive FDA 510(k) clearance?

MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER received FDA 510(k) clearance on 2008-10-01, under 510(k) number K082707.

Who is the listed applicant for MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER?

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

What is the FDA product code for MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER?

The FDA product code for MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER is ILY.

Related Clinical Trials

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Other records listing Medx Electronics, Inc. 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.

K050022MEDX HOMEK032231MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASERK024310NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORYK021985MEDX LCS LASER SERIESK020017MEDX 1000 SERIES

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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