FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
LED Therapy Device (Planar LED/Planar LED mini)
K Number: K220103
·
Decision Apr 12, 2022
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- LED Therapy Device (Planar LED/Planar LED mini)
- K Number
- K220103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Leaflife Technology Co., Ltd.
- Date Received
- January 12, 2022
- Decision Date
- April 12, 2022
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Shenzhen Leaflife Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253219 | LeafPure-Echo (LM-LPNdA) | Nov 25, 2025 | Substantially Equivalent |
| K250916 | WinForth (LM-E470KA) | Aug 14, 2025 | Substantially Equivalent |
| K233760 | Mjolnir Pro. (Multielectrode plasma) | Feb 20, 2024 | Substantially Equivalent |
| K230362 | Planar LED mate | Sep 11, 2023 | Substantially Equivalent |
| K212697 | Leaf Smooth | Nov 19, 2021 | Substantially Equivalent |
| K202980 | Laser Therapy Device | Nov 19, 2020 | Substantially Equivalent |