Ulike Reglow Light Therapy Device (UM10)— 510(k) K260511
Substantially EquivalentShenzhen Ulike Smart Electronics Co., Ltd.
FDA 510(k) clearance K260511 for Ulike Reglow Light Therapy Device (UM10), Substantially Equivalent on 2026-03-16. Applicant: Shenzhen Ulike Smart Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Ulike Smart Electronics Co., Ltd.
- Product code
- Code OHS
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Shenzhen, CN
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- K251984 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
Adverse events under product code OHS
product code OHS- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.