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FDA 510(k)

PHASER-2000

K-Number: K982546 · 1998-09-22

ApplicantDiomedics, Inc.
Decision Date1998-09-22
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PHASER-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Diomedics, Inc.. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K982546. 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 PHASER-2000?

PHASER-2000 is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Diomedics, Inc.. The 510(k) number is K982546.

When did PHASER-2000 receive FDA 510(k) clearance?

PHASER-2000 received FDA 510(k) clearance on 1998-09-22, under 510(k) number K982546.

Who is the listed applicant for PHASER-2000?

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

What is the FDA product code for PHASER-2000?

The FDA product code for PHASER-2000 is ILY.

Related Clinical Trials

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.

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Other records listing Diomedics, 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.

K073503VERSA LITEK926224DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS

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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