510(k) K242755
- Device
- Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
- Applicant
- Gigaalaser Company , Ltd.
- 510(k) number
- K242755
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-19
- Date received
- 2024-09-12
- 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
- N
Related Records
Applicant Contact
- Contact
- Xinxing Nie
- Address
- B15-8f, Wuhan Hi-Tech Medical Device Park, #818 Gaoxin Rd. Wuhan CN
FDA Registration Numbers
- 3003895865
- 1725006
- 3010144038
- 3014527699
- 3012176966
- 3023344923
- 3008539245
- 8040537
- 3043709770
- 3017103444
- 3017236146
- 3012446970
- 3042269047
- 3017961176
- 3027745834
- 3033850996
- 3003015433
- 3018994966
- 3016099060
- 2027755
- 3043840133
- 3012541016
- 3027509245
- 3005170249
- 3010162243
- 3027328721
- 3006228861
- 3011066654
- 1225072
- 1419489
- 3026939957
- 3013057712
- 2013558
- 3014386328
- 3017124433
- 3042278987
- 3042865685
- 3028172072
- 3007278668
- 3030708724
- 3015287734
- 3029950834
- 3019734322
- 3010683450
- 9615330
- 3015993373
- 3015283772
- 3016816791
- 3043503817
- 3015313684
- 3029083714
- 3013178978
- 3010055391
- 3015139785
- 3005327291
- 3036780813
- 3035878914
- 3007165178
- 3035375032
- 3044596934
- 3030563436
- 3030926983
- 3042277467
- 3016980707
- 3030516327
- 3008756544
- 3012430589
- 2954354
- 3011670002
- 3020978007
- 3033450607
- 3030648305
- 3005581016
- 3006190476
- 3018317166
- 3011077581
- 3012657194
- 3037609256
- 3043709874
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16977331780059 | GIGAA | Gigaalaser Company Ltd. | 2025-08-15 |
| 16977331780042 | GIGAA | Gigaalaser Company Ltd. | 2025-08-13 |
| 16977331780035 | GIGAA | Gigaalaser Company Ltd. | 2025-08-13 |
| 16977331780028 | GIGAA | Gigaalaser Company Ltd. | 2025-08-13 |
| 16977331780011 | GIGAA | Gigaalaser Company Ltd. | 2025-08-13 |
Other 510(k) Records For Product Code ILY
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253965 | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) | Wuhan PHOMED Technology Company , Ltd. | 2026-03-19 |
| 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 |