510(k) K243423— LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)

Substantially Equivalent

Shenzhen Rainbow Technology Co., Ltd.

Clearance details

Applicant: Shenzhen Rainbow Technology Co., Ltd.
Product code: Code OHS
Advisory panel: General, Plastic Surgery
Date received: 2024-11-04
Decision date: 2025-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code OHS

product code OHS

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.