510(k) clearances

AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3)

Shenzhen Accompany Technology Co., Ltd. · General, Plastic Surgery

K262932Substantially EquivalentTraditionalOHS
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
General, Plastic Surgery
Address 1
25th Floor, Gaoxin Community United Headquarters Bldg., #63,
Statement or summary
Summary
Product code
OHS
Zip code
518000
Applicant
Shenzhen Accompany Technology Co., Ltd.
Decision date
2026-10-19
Decision code
SESE
Country code
CN
Device name
AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3)
Advisory committee
SU
Contact
Chan Fu
K number
K262932
Date received
2026-08-21
Review advisory committee
SU
Postal code
518000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Light Based Over The Counter Wrinkle Reduction
Medical specialty description
General, Plastic Surgery
Regulation number
878.4810
Device class
2
Registration number
3012657194, 3031595583, 3010027944, 3014545271, 3009102830, 3012113199, 3008345424, 3043749884, 3007238544, 3010724743, 3006546131, 3012294783, 3018259873, 3030194742, 3038373471, 3048342015, 3044622318, 3012327767, 3013423303, 3023371360, 3021282471, 3048086714, 3042261413, 3036720861, 3035785623, 3029944286, 3013178978, 3013738756, 3033435469, 3009765778, 3015109022, 1318319, 3004126239, 1832894, 3016055197, 3015313684, 3042970900, 3007554929, 3010677917, 3043710338 +94 more
FEI number
3012657194, 3031595583, 3010027944, 3014545271, 3009102830, 3012113199, 3008345424, 3043749884, 3007238544, 3010724743, 3006546131, 3012294783, 3018259873, 3030194742, 3038373471, 3048342015, 3044622318, 3012327767, 3013423303, 3023371360, 3021282471, 3048086714, 3042261413, 3036720861, 3035785623, 3029944286, 3013178978, 3013738756, 3033435469, 3009765778, 3015109022, 1318319, 3004126239, 1832894, 3016055197, 3015313684, 3042970900, 3007554929, 3010677917, 3043710338 +94 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.