510(k) K123474
- Device
- AVANT LASER
- Applicant
- AVANT WELLNESS SYSTEMS, LLC
- 510(k) number
- K123474
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-12-03
- Date received
- 2012-11-13
- Regulation
- 890.5500
- Classification name
- Lamp, Infrared, Therapeutic Heating
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDY HEWITSON
- Address
- 1020 Calle Cordillera, Suite 107 San Clemente CA US 92673 92673
FDA Registration Numbers#
- 3007608780
- 3045031090
- 3013481783
- 3002824588
- 3012316249
- 3021574099
- 3045925752
- 3022426824
- 3013929792
- 3017415521
- 3012262584
- 3015195058
- 3010730876
- 3005695724
- 3015974280
- 3010120748
- 3017618900
- 3013057712
- 3015989868
- 3013846070
- 3016019469
- 3006849751
- 3006984716
- 3008064428
- 3010894709
- 3038622006
- 3010053203
- 3019770328
- 3004027973
- 9614977
- 1419489
- 3044989687
- 3014680784
- 3018126456
- 1725006
- 3025421718
- 3040389273
- 3027200295
- 3006555617
- 3039443708
- 3017264244
- 3029992391
- 3015456954
- 3027645761
- 3025104654
- 3045954069
- 3009973354
- 3037031835
- 3001431138
- 3009323672
- 3043840133
- 3019623342
- 3006985163
- 3022553912
- 3014601569
- 3019778249
- 1528161
- 3029950834
- 3042261334
- 3014073090
- 3020491484
- 3034241144
- 3021282471
- 2013558
- 3023237645
- 3007085226
- 3030412417
- 3042277467
- 3038319732
- 3030234143
- 3031191551
- 3005515469
- 3011258423
- 3027263493
- 3019864920
- 3016610172
- 3015262665
- 3031980484
- 3009346095
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases