Medical devices; general and plastic surgery devices; classification of the focused ultrasound stimulator system for aesthetic use. Final rule.
【연구 목적】 식품의약청(FDA)은 미용 목적으로 사용되는 집속 초음파 자극기 시스템(focused ultrasound stimulator system)을 특수 통제(special controls)가 적용되는 제2군(Class II) 의료기기로 분류하는 최종 규칙을 발표하였다.
APA
(2011). Medical devices; general and plastic surgery devices; classification of the focused ultrasound stimulator system for aesthetic use. Final rule.. Federal register, 76(139), 43119-21.
MLA
. "Medical devices; general and plastic surgery devices; classification of the focused ultrasound stimulator system for aesthetic use. Final rule.." Federal register, vol. 76, no. 139, 2011, pp. 43119-21.
PMID
21774154
Abstract
The Food and Drug Administration (FDA) is classifying the focused ultrasound stimulator system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
추출된 의학 개체 (NER)
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 기타 | class II
|
scispacy | 1 |
MeSH Terms
Device Approval; Equipment Safety; High-Intensity Focused Ultrasound Ablation; Humans; Surgery, Plastic; Ultrasonic Therapy; United States; United States Food and Drug Administration