Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K220381
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K220381
Device Name
Powered Laser Surgical Instrument
Applicant
Beijing LaserTell Medical Co., Ltd.
Block1, No.12 Jingsheng South 2nd Road, JQ Science Park,
Tongzhou District
Beijing 101149 CN
Other 510(k) Applications for this Company
Contact
Zeng Xun
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/10/2022
Decision Date
05/20/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact