Home / 510(k) Clearances / K253965

510(k) K253965

CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) by Wuhan PHOMED Technology Company , Ltd. — Product Code ILY

K253965 is an FDA 510(k) premarket notification submitted by Wuhan PHOMED Technology Company , Ltd. for the device "CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)". The FDA issued a decision of Substantially Equivalent on March 19, 2026. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2026
Date Received
December 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

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FDA data resources