510(k) K222205
- Device
- Cold Sore Device (Model: QPZ-01)
- Applicant
- Light Tree Ventures Europe B.V.
- 510(k) number
- K222205
- Product code
- OKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-07
- Date received
- 2022-07-25
- Regulation
- 878.4860
- Classification name
- Light Based Treatment For Cold Sores Herpes Simplex Virus-1
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alain Dijkstra
- Address
- Laan Van Ypenburg 108, 2497 Gc, The Hague, The Netherlands Hague NL
FDA Registration Numbers#
- 3018949797
- 3011644607
- 3020491484
Source Documents#
Other 510(k) Records For Product Code OKJ #
Legacy Summary#
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FDA Review#
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