# Skylark Device & Systems Co., Ltd.

- Location (FDA's records): Taipei, TW
- FDA decisions: 6 (2000–2005): 6 510(k) clearances
- Product codes: GYB (1), ILY (1), IPF (1), LIH (1), GZJ (1), KPI (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 4 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Skylark Device Co., Ltd.: 1 (https://510kreport.com/company/skylark-device)
- Rs Medical: 1 (https://510kreport.com/company/rs-medical)

## Firms that cite its devices most
- Endurance Therapeutics: 1 (https://510kreport.com/company/endurance-therapeutics)
- Shockim Enterprises, Ltd.: 1 (https://510kreport.com/company/shockim-enterprises)
- Surgitech, Inc.: 1 (https://510kreport.com/company/surgitech)

## Its most-cited devices
- K992652: SD-730 IF-SDS, Perfect Pulse IF-SDS (2000), cited by 2
- K050174: Bio-Stim Kit (2005), cited by 2

## Recent decisions
- K053007: Skylark Uro Probe (Dec 5, 2005)
- K050174: Bio-Stim Kit (Sep 7, 2005)
- K043306: Skylark Infrared Photon Stimulator, Models, SD-956IR and SD-100IR (Jun 6, 2005)
- K034005: SDS-4I (Nov 18, 2004)
- K002832: Conductive Gel for Ultrasound (Aug 6, 2001)
- K992652: SD-730 IF-SDS, Perfect Pulse IF-SDS (Feb 3, 2000)

Source page: https://510kreport.com/company/skylark-device-systems