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FDA 510(k)

SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR

K-Number: K043306 · 2005-06-06

ApplicantSkylark Device & Systems Co., Ltd.
Decision Date2005-06-06
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR is the device name listed in this FDA 510(k) record. The listed applicant is Skylark Device & Systems Co., Ltd.. It received FDA 510(k) clearance on 2005-06-06 under 510(k) number K043306. 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 SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR?

SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR is a medical device that received FDA 510(k) clearance on 2005-06-06. The listed applicant is Skylark Device & Systems Co., Ltd.. The 510(k) number is K043306.

When did SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR receive FDA 510(k) clearance?

SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR received FDA 510(k) clearance on 2005-06-06, under 510(k) number K043306.

Who is the listed applicant for SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR?

The FDA 510(k) record lists Skylark Device & Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR?

The FDA product code for SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR is ILY.

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Other records listing Skylark Device & Systems Co., Ltd. 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.

K053007SKYLARK URO PROBEK050174BIO-STIM KITK034005SDS-4IK002832CONDUCTIVE GEL FOR ULTRASOUNDK992652SD-730 IF-SDS, PERFECT PULSE IF-SDS

Related Devices (Code: ILY)

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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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