CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)
FDA 510(k) K253965 · Wuhan PHOMED Technology Company , Ltd.
510(k) numberK253965
Submission
- Device name
- CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)
- Applicant
- Wuhan PHOMED Technology Company , Ltd.
Wuhan, CN - Received
- December 11, 2025
- Decision date
- March 19, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
Other 510(k)s with product code ILY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…ILY · Traditional | Gigaalaser Company , Ltd. | 05/19/2025SE |
| K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)ILY · Traditional | Cure Point Therapeutics, Inc. | 10/15/2024SE |
| K223642 | LED Lip Perfector, model: ZC-05ILY · Traditional | Light Tree Ventures Europe B.V. | 03/09/2023SE |
| K221189 | Oliz LTB-1000AILY · Traditional | Ltbio Co., Ltd. | 08/29/2022SE |
| K213524 | CytonPro-5000ILY · Traditional | Cytonsys, Inc. | 08/10/2022SE |
| K202028 | dermalux Flex MDILY · Traditional | Aesthetic Technology, Ltd. | 12/16/2020SE |
| K171087 | AXON IR Heat LampILY · Traditional | Crystal Medtech, LLC | 07/07/2017SE |
| K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM…ILY · Traditional | Healthlight, LLC | 06/13/2017SE |
| K170068 | Softcure 96ILY · Traditional | Wellray Medical Laser, Inc. | 05/05/2017SE |
| K162590 | Bashan TDP Heat LampILY · Traditional | Chogqing Yuhe Medical Instruments Co., Ltd. | 02/14/2017SE |
Questions and answers
When was CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) cleared by the FDA?
CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) (K253965) received a 510(k) decision of Substantially Equivalent on March 19, 2026, 98 days after the submission was received.
What is the product code of K253965?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.