Irradiation Cosmetic Device
FDA 510(k) clearance K192552 · decided 2020-04-17
Clearance details
- K-number
- K192552
- Device name
- Irradiation Cosmetic Device
- Applicant
- Chongqing Peninsula Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-17
- Decision date
- 2020-04-17
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- OAP
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Jiulongpo District, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.