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
- No
Applicant Contact#
- Contact
- Xinxing Nie
- Address
- B15-8f, Wuhan Hi-Tech Medical Device Park, #818 Gaoxin Rd. Wuhan CN
FDA Registration Numbers#
- 3036780813
- 3008592814
- 3017264244
- 3025104654
- 3015169474
- 3005545844
- 3008393409
- 3026312077
- 2013558
- 3014545271
- 3010027944
- 3015152461
- 3033920804
- 3040389697
- 3043503817
- 3004135764
- 3016171836
- 3014527699
- 3017199264
- 3017618900
- 3026939957
- 3016055197
- 3012446970
- 3014977697
- 3009323672
- 3018188848
- 3011108368
- 3014073090
- 1225072
- 3018949797
- 3010677917
- 3043709874
- 3024892917
- 3012125201
- 3015522128
- 3034241144
- 3045010480
- 3016002329
- 3034609017
- 3016610172
- 3017206625
- 3020491484
- 3009765778
- 3038636181
- 3044882985
- 3012386142
- 3023808059
- 3019577501
- 3016750352
- 3022553912
- 3040502961
- 3034745472
- 3038700839
- 3043126851
- 3044572954
- 3021386683
- 3017706553
- 3007744197
- 3033511105
- 3043177693
- 9616086
- 3016496662
- 3017619615
- 3011077581
- 3011164092
- 3043709770
- 3038319732
- 3042277467
- 3030563436
- 3011670002
- 3011387816
- 3021482081
- 3020237751
- 3029328624
- 3004505220
- 3031182687
- 3003895865
- 3019778249
- 3035186104
Source Documents#
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 |