510(k) K230076

Device: Enhanced AURORA? Medical Diode System, and related accessories
Applicant: Psoria-Shield, Inc.
510(k) number: K230076
Product code: FTC
Decision: Substantially Equivalent (SESE)
Decision date: 2023-03-08
Date received: 2023-01-10
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: John Yorke
Address: 409 Mandeville St. Utica NY US 13502 13502

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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