LED Facial Mask— 510(k) K213056
Substantially EquivalentShenzhen Osto Technology Company Limited
FDA 510(k) clearance K213056 for LED Facial Mask, Substantially Equivalent on 2022-07-07. Applicant: Shenzhen Osto Technology Company Limited. Device class: 2.
Clearance details
- Applicant
- Shenzhen Osto Technology Company Limited
- Product code
- Product 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
- Shenzhen, CN
Recent devices under product code OLP
view allMore clearances from Shenzhen Osto Technology Company Limited
view all- K211942 — Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
- K211736 — Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
- K210756 — Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
- K190783 — Health Expert Electronic Stimulator (model: AST-300L)
- K190673 — Health Expert Electronic Stimulator
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.