Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K213039
Device Classification Name
Over-The-Counter Powered Light Based Laser For Acne
More FDA Info for this Device
510(K) Number
K213039
Device Name
Over-The-Counter Powered Light Based Laser For Acne
Applicant
Li-Tek Electronics Technology C0., Ltd
No. 8-13, the industrial park of Jinshagang, Shixia village,
Dalang town
Dongguan 523106 CN
Other 510(k) Applications for this Company
Contact
Barry Yuan
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OLP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/22/2021
Decision Date
05/25/2022
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