510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sanhe Laserconn Tech Co., Ltd.

Langfang Hebei, CN

SANHE LASERCONN TECH CO., LTD. appears in FDA device records in Langfang Hebei, CN. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Sanhe Laserconn Tech Co., Ltd. in 2022.

Clearances by year, as a table
510(k) clearance decisions for Sanhe Laserconn Tech Co., Ltd., by decision year
YearClearances
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)GEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Sanhe Laserconn Tech Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30121252013012125201SANHE LASERCONN TECH CO., LTD.X03-A Building, Baishijingu Industry Park, Yanjiao, Langfang Hebei 065201 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

MDM coverage

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Data as of , FDA export datePage updated Source: openFDA, public domain