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FDA 510(k)

INFRARED DELUXE

K-Number: K890586 · 1989-08-22

ApplicantHealthteam
Decision Date1989-08-22
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INFRARED DELUXE is the device name listed in this FDA 510(k) record. The listed applicant is Healthteam. It received FDA 510(k) clearance on 1989-08-22 under 510(k) number K890586. 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 INFRARED DELUXE?

INFRARED DELUXE is a medical device that received FDA 510(k) clearance on 1989-08-22. The listed applicant is Healthteam. The 510(k) number is K890586.

When did INFRARED DELUXE receive FDA 510(k) clearance?

INFRARED DELUXE received FDA 510(k) clearance on 1989-08-22, under 510(k) number K890586.

Who is the listed applicant for INFRARED DELUXE?

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

What is the FDA product code for INFRARED DELUXE?

The FDA product code for INFRARED DELUXE is ILY.

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Other records listing Healthteam 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.

K890585INFRARED HEXK890588GENTLE EXPRESSIONS ELECTRIC BREAST PUMPK852458HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145K852457HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165K852653HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115K852459HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175

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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

View on FDA Database →

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

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