LED Light Therapy Mask (RT01)— 510(k) K242068
Substantially EquivalentNingbo Dechang Electrical Machinery Made Co.,Ltd
FDA 510(k) clearance K242068 for LED Light Therapy Mask (RT01), Substantially Equivalent on 2025-04-04. Applicant: Ningbo Dechang Electrical Machinery Made Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Ningbo Dechang Electrical Machinery Made Co.,Ltd
- Product code
- Code OLP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yuyao, CN
Recent devices under product code OLP
view all- K253878 — LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
- K251843 — Erchonia EVRL
- K243555 — LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
- K232656 — BLU TOTALE (Model: ENEOB852)
- K230490 — PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
Adverse events under product code OLP
product code OLP- 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.