FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
K Number: K251825
·
Decision Oct 1, 2025
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
152
Applicant Total
23
Review Days
110
Basic Information
- Device Name
- Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
- K Number
- K251825
- 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 Ulike Smart Electronics Co., Ltd.
- Date Received
- June 13, 2025
- Decision Date
- October 1, 2025
- Product Code
- OHS
- 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 |
|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Shenzhen Ulike Smart Electronics Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K261325 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | May 21, 2026 | Substantially Equivalent |
| K260742 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) | May 5, 2026 | Substantially Equivalent |
| K260511 | Ulike Reglow Light Therapy Device (UM10) | Mar 16, 2026 | Substantially Equivalent |
| K252804 | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, | Oct 1, 2025 | Substantially Equivalent |
| K251984 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | Jul 24, 2025 | Substantially Equivalent |
| K250942 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) | Jul 11, 2025 | Substantially Equivalent |
| K250938 | Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) | May 23, 2025 | Substantially Equivalent |
| K243749 | Jmoon Conductive Gel | Apr 8, 2025 | Substantially Equivalent |
| K250194 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) | Mar 26, 2025 | Substantially Equivalent |
| K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) | Feb 3, 2025 | Substantially Equivalent |