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
Related Records
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
- 3029083714
- 1055581
- 3031182687
- 3009765778
- 3030234143
- 3021743553
- 3035374386
- 3042371408
- 3016879560
- 3017618900
- 3030151584
- 3020659203
- 3018317166
- 3007674911
- 3006978331
- 3042269047
- 3010314781
- 3012184208
- 3018994966
- 3014158749
- 3008959444
- 3018608545
- 3042261334
- 3006475220
- 9612147
- 3034204485
- 3029950834
- 9616086
- 3019015047
- 3005515469
- 3008592814
- 3023344923
- 3016099060
- 3013178978
- 3012512142
- 3007689716
- 3004264602
- 3012386142
- 3011164092
- 3027327500
- 3044470839
- 3013591868
- 3011258423
- 3019623342
- 3029633864
- 3011249646
- 3040387923
- 3043165979
- 1055758
- 3023876581
- 3012327767
- 3013019295
- 3012657194
- 3014296246
- 3016071154
- 3011506263
- 3013052700
- 3026038437
- 3001431138
- 3030412027
- 3037013920
- 3010689958
- 3012147801
- 3023808059
- 3030498909
- 3042278987
- 3010280625
- 3012113199
- 3014386328
- 3037609256
- 3030508288
- 3015924074
- 3043661837
- 3003895865
- 3004505220
- 3033845665
- 3040389273
- 2087190
- 3013002868
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06976563460060 | CureLight Medical Diode Laser Systems | Wuhan PHOMED Technology Co., Ltd. | 2025-10-09 |
| 06976563460053 | CureLight Medical Diode Laser Systems | Wuhan PHOMED Technology Co., Ltd. | 2025-10-09 |
| 06976563460046 | CureLight Medical Diode Laser Systems | Wuhan PHOMED Technology Co., Ltd. | 2025-10-09 |
| 06976563460039 | CureLight Medical Diode Laser Systems | Wuhan PHOMED Technology Co., Ltd. | 2025-10-09 |
| 06976563460022 | CureLight Medical Diode Laser Systems | Wuhan PHOMED Technology Co., Ltd. | 2025-10-09 |
| 06976563460015 | CureLight Medical Diode Laser Systems | Wuhan PHOMED Technology Co., Ltd. | 2025-10-09 |
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|---|---|---|---|
| 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 |