AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3)— 510(k) K262932
Substantially EquivalentShenzhen Accompany Technology Co., Ltd.
FDA 510(k) clearance K262932 for AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3), Substantially Equivalent on 2026-10-19. Applicant: Shenzhen Accompany Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Accompany Technology Co., Ltd.
- Product code
- Product 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
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OHS
view all- K262984 — Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06, Bway-FN01, Bway-E01, Bway-E02)
- K262752 — Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)
- K260767 — Facial Beauty Device (Facial Mask LED Beauty Device A-901 +2 more
- K261602 — Eye Recovery Pro (PH-e03)
- K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
More clearances from Shenzhen Accompany Technology Co., Ltd.
view allAdverse 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.