510(k) clearances

Nd: YAG Laser Therapy Systems

Sanhe Meditech Co., Ltd. · General, Plastic Surgery

K260375Substantially EquivalentTraditionalGEX
Open FDA's page for this record
Third party flag
N
City
Sanhe
Advisory committee description
General, Plastic Surgery
Address 1
#15 Bldg, Zhongnan High-Tech Industrial Park, Liushan St.
Address 2
Yanjiao
Statement or summary
Summary
Product code
GEX
Zip code
065201
Applicant
Sanhe Meditech Co., Ltd.
Decision date
2026-03-31
Decision code
SESE
Country code
CN
Device name
Nd: YAG Laser Therapy Systems
Advisory committee
SU
Contact
Xiaoxia Song
K number
K260375
Date received
2026-02-05
Review advisory committee
SU
Postal code
065201
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Powered Laser Surgical Instrument
Medical specialty description
General, Plastic Surgery
Regulation number
878.4810
Device class
2
Registration number
3033273466, 1221275, 3021550489, 3014225468, 3005855240, 3026668625, 3010902869, 3006082230, 3002991496, 3004378299, 3006546082, 3004884150, 9614977, 3043729119, 3012157621, 3004642415, 3012322232, 3020900954, 9611516, 3011782009, 3006555617, 3014388884, 3010933841, 3009298127, 3019252665, 3041275224, 3023808190, 3009453258, 3020770009, 3010273872, 2529392, 3034630389, 3012125201, 3016170453, 3033511105, 8043792, 3011310540, 2939653, 3033884002, 3006985208 +454 more
FEI number
3033273466, 1221275, 3021550489, 3001415984, 3014225468, 3005855240, 1000120768, 3010902869, 3026668625, 3006082230, 3002991496, 3004378299, 3006546082, 3004884150, 3043729119, 3012157621, 3004642415, 3012322232, 3020900954, 3003719498, 3006555617, 3014388884, 3010933841, 3009298127, 3019252665, 3041275224, 3023808190, 3009453258, 3020770009, 3010273872, 3034630389, 3012125201, 3016170453, 3033511105, 1000114111, 3011310540, 2939653, 3033884002, 3006985208, 3013503862 +452 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.