510(k) clearances

CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)

Shenzhen Kaiyan Medical Equipment Co., Ltd. · General, Plastic Surgery

K242593Substantially EquivalentTraditionalOHS
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
General, Plastic Surgery
Address 1
Bldg.#3 And Bldg.#5, 40th Of Fuxin St.
Address 2
Huaide Community Fuyong Town
Statement or summary
Summary
Product code
OHS
Zip code
518103
Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Decision date
2025-02-14
Decision code
SESE
Country code
CN
Device name
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)
Advisory committee
SU
Contact
Alain Dijkstra
K number
K242593
Date received
2024-08-30
Review advisory committee
SU
Postal code
518103
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
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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.