308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)— 510(k) K242977
Substantially EquivalentXuzhou Kernel Medical Equipment Co., Ltd.
FDA 510(k) clearance K242977 for 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K), Substantially Equivalent on 2025-02-06. Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Xuzhou Kernel Medical Equipment Co., Ltd.
- Product code
- Code FTC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4630
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xuzhou, CN
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