LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)— 510(k) K243555
Substantially EquivalentShenzhen Eyco Technology Co., Ltd.
FDA 510(k) clearance K243555 for LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A), Substantially Equivalent on 2025-02-05. Applicant: Shenzhen Eyco Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Eyco Technology 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
- Guangdong, CN
Recent devices under product code OLP
view all- K253878 — LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
- K251843 — Erchonia EVRL
- K242068 — LED Light Therapy Mask (RT01)
- 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.