510(k) K253965
- Device
- 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.
- 510(k) number
- K253965
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-19
- Date received
- 2025-12-11
- Regulation
- 890.5500
- Classification name
- Lamp, Infrared, Therapeutic Heating
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Huang Bill
- Address
- Rm. 02, 3f, Bldg. 2, Gezhouba Sun City, # 40 Gaoxin 4th Rd., E. Lake New Technology Development Zone Wuhan CN 430200 430200
FDA Registration Numbers#
- 3019577501
- 3029328624
- 3009437400
- 1721293
- 3014545271
- 9680934
- 3009323672
- 3008539245
- 3036675345
- 3040314796
- 3035374386
- 1832894
- 3038636181
- 3024838204
- 3023348662
- 3038319732
- 3005739661
- 3011654863
- 3030540470
- 3023339107
- 3025104654
- 3016055197
- 3025936823
- 3034288049
- 3019623342
- 3007744197
- 3042277640
- 3014527699
- 3032062344
- 3043165979
- 3042261334
- 3034286426
- 3033813891
- 3015646995
- 3031182687
- 3023237645
- 3008592814
- 3026322014
- 3015924074
- 3006984716
- 3007608780
- 3003851819
- 3022553912
- 3033793026
- 3014737458
- 3033796950
- 3010027944
- 3014577013
- 3013178978
- 3003725190
- 3010677917
- 3021482081
- 3003899624
- 3012482375
- 3013397886
- 3017415521
- 3043138911
- 3029997768
- 3010894709
- 3021599225
- 3023229437
- 3044921223
- 3023876581
- 3027509245
- 3030926983
- 3020221089
- 3043710338
- 3018123168
- 3016496662
- 3017140525
- 3030542040
- 3030412027
- 3042269047
- 3004724437
- 3012725363
- 3017124433
- 3004126239
- 8043894
- 3043713503
Source Documents#
Other 510(k) Records For Product Code ILY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | Gigaalaser Company , Ltd. | 2025-05-19 |
| K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | Cure Point Therapeutics, Inc. | 2024-10-15 |
| K223642 | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | 2023-03-09 |
| K221189 | OLIZ LTB-1000A | Ltbio Co., Ltd. | 2022-08-29 |
| K213524 | CytonPro-5000 | Cytonsys, Inc. | 2022-08-10 |
| K202028 | dermalux Flex MD | Aesthetic Technology, Ltd. | 2020-12-16 |
| K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | 2017-07-07 |
| K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System | Healthlight, LLC | 2017-06-13 |
| K170068 | Softcure 96 | Wellray Medical Laser, Inc. | 2017-05-05 |
| K162590 | Bashan TDP Heat Lamp | Chogqing Yuhe Medical Instruments Co., Ltd. | 2017-02-14 |
| K162763 | Vevazz LED Heat Lamp | Vevazz, LLC | 2017-01-05 |
| K160849 | WS(TM) Far-Infrared Therapy Unit, Model KP-B210 | Ws Far IR Medical Technology Co., Ltd. | 2016-12-15 |
| K152087 | HeatLux Pro II | Home Skinovations , Ltd. | 2016-07-29 |
| K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016-07-26 |
| K152461 | The Time Machine Series Lasers | Medical Lasers Manufacturer, Inc. | 2016-07-08 |