Clearance Summary
SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR received FDA 510(k) clearance under submission number K043306, sponsored by Skylark Device & Systems Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2005-06-06.
- Submission: K043306
- Applicant / Sponsor: Skylark Device & Systems Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2005-06-06
Classification & Regulation
This clearance is catalogued under FDA product code ILY and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.