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FDA 510(k)

SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018

K-Number: K020462 · 2002-09-16

ApplicantRolor Electronics Corp.
Decision Date2002-09-16
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018 is the device name listed in this FDA 510(k) record. The listed applicant is Rolor Electronics Corp.. It received FDA 510(k) clearance on 2002-09-16 under 510(k) number K020462. 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 SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018?

SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018 is a medical device that received FDA 510(k) clearance on 2002-09-16. The listed applicant is Rolor Electronics Corp.. The 510(k) number is K020462.

When did SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018 receive FDA 510(k) clearance?

SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018 received FDA 510(k) clearance on 2002-09-16, under 510(k) number K020462.

Who is the listed applicant for SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018?

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

What is the FDA product code for SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018?

The FDA product code for SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018 is ILY.

Related Clinical Trials

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Other records listing Rolor Electronics Corp. 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.

K020130ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016MK021430SANIDAD TENS-DUO MODE GP8016NK020464SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646

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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