510(k) K141861
- Device
- HILTHERA 4.0
- Applicant
- JEISYS MEDICAL, INC.
- 510(k) number
- K141861
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-01-07
- Date received
- 2014-07-10
- 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
- Priscilla Chung
- Address
- 2651 E. Chapman Ave., Suite 110 Fullerton CA US 92831 92831
FDA Registration Numbers#
- 3010894709
- 3031595583
- 3012113199
- 3031075901
- 3019015047
- 3010144038
- 3005956028
- 3017837510
- 3027605507
- 3015313684
- 3008648418
- 3020887108
- 3010314781
- 3011644607
- 3003015433
- 3021482081
- 3034733556
- 8040537
- 3045954069
- 3004139830
- 3022426824
- 3017207289
- 3006978331
- 3010169226
- 3015924074
- 3023344923
- 8010720
- 3023808059
- 9614977
- 3036675345
- 3005170249
- 3027303024
- 3010280625
- 3034241144
- 3010360273
- 3008064428
- 3016915446
- 3017618900
- 3042254846
- 3015169474
- 3011506263
- 3013069546
- 3023339107
- 3004112621
- 3008921662
- 3014158749
- 3017382141
- 3012125201
- 3030540470
- 3020977186
- 3042261334
- 3031191551
- 3035879449
- 3012512142
- 3010027944
- 3016019469
- 3013481783
- 3020978007
- 3033796950
- 3017435733
- 3016055197
- 3017153262
- 3043138914
- 3015287734
- 3014573304
- 3010677917
- 3035374386
- 3008592814
- 3012799115
- 3003082988
- 3016071154
- 3043713503
- 3043126900
- 3030648305
- 3029972385
- 3045978226
- 3033436421
- 3030220360
- 3017181358
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 |
| 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#
summary
FDA Review#
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