Dr. pen Microneedling System— 510(k) K230420
Substantially EquivalentGuangzhou Ekai Electronic Technology Co., Ltd.
FDA 510(k) clearance K230420 for Dr. pen Microneedling System, Substantially Equivalent on 2023-08-11. Applicant: Guangzhou Ekai Electronic Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Ekai Electronic Technology Co., Ltd.
- Product code
- Code QAI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4430
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code QAI
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