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FDA 510(k) Application Details - K250467
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K250467
Device Name
Laser, Comb, Hair
Applicant
Shenzhen Idea Light Limited
3rd Floor, Block B, Shengdelan Industry Park,
Longhua District
Shenzhen 518110 CN
Other 510(k) Applications for this Company
Contact
Nicole Liu
Other 510(k) Applications for this Contact
Regulation Number
890.5500
More FDA Info for this Regulation Number
Classification Product Code
OAP
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More FDA Info for this Product Code
Date Received
02/18/2025
Decision Date
06/05/2025
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K250467
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