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FDA 510(k)

ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE

K-Number: K033768 · 2004-02-17

ApplicantAltus Medical, Inc.
Decision Date2004-02-17
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Altus Medical, Inc.. It received FDA 510(k) clearance on 2004-02-17 under 510(k) number K033768. 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 ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE?

ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE is a medical device that received FDA 510(k) clearance on 2004-02-17. The listed applicant is Altus Medical, Inc.. The 510(k) number is K033768.

When did ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE receive FDA 510(k) clearance?

ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE received FDA 510(k) clearance on 2004-02-17, under 510(k) number K033768.

Who is the listed applicant for ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE?

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

What is the FDA product code for ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE?

The FDA product code for ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE is ILY.

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Other records listing Altus Medical, 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.

K023954ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIESK022226ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELSK014040FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS

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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