510(k) K200971

Device: 308nm Excimer System
Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
510(k) number: K200971
Product code: FTC
Decision: Substantially Equivalent (SESE)
Decision date: 2020-12-15
Date received: 2020-04-13
Regulation: 878.4630
Classification name: Light, Ultraviolet, Dermatological
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Jing Wang
Address: Kernel Mansion, Economic Development District Xuzhou CN 221004 221004

FDA Registration Numbers

3014226003
3007699081
1526255
3009736547
9680413
3003882673
3002672225
3016746323
1318319
3015060197
1528161
3004167969
3011024620
3017406171
3004193926
3008255748
3005205318
1022129
3013229265
3008393409
3006580954
3023306694
3008872264
3004374705

Source Documents

510(k) summary PDF

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