SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR— 510(k) K043306

Substantially Equivalent

Skylark Device & Systems Co., Ltd.

FDA 510(k) clearance K043306 for SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR, Substantially Equivalent on 2005-06-06. Applicant: Skylark Device & Systems Co., Ltd..

Clearance details

Applicant: Skylark Device & Systems Co., Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2004-12-01
Decision date: 2005-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

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Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.