Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K202043
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K202043
Device Name
Powered Laser Surgical Instrument
Applicant
Ilooda Co Ltd
120, Jangan-Ro 458 Beon-Gil Jangan-Gu
Suwon-Si Gyeonggido 16200 KR
Other 510(k) Applications for this Company
Contact
Kevin Walls
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
07/23/2020
Decision Date
04/23/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact