510(k) K101267
- Device
- PREMIO 10 MOXA
- Applicant
- SEDATELEC
- 510(k) number
- K101267
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-12-03
- Date received
- 2010-05-05
- 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
- Kevin Walls
- Address
- 5401 S Cottonwood Ct. Greenwood Village CO US 80121 80121
FDA Registration Numbers#
- 3012657194
- 2029015
- 3035374295
- 3033450607
- 3044596934
- 3021282471
- 3010894709
- 3006985163
- 3033813891
- 3021376102
- 3016446653
- 3011539161
- 3039443708
- 3003654318
- 3013057712
- 3006849751
- 3023876581
- 3014184914
- 3021594370
- 3030648305
- 3018123168
- 3015466811
- 3004126239
- 3016019469
- 3007608780
- 3015989868
- 3006984716
- 2027755
- 3036675345
- 3004724437
- 3010677917
- 3017199264
- 3014577013
- 3010709091
- 3017236146
- 3038620598
- 3001224205
- 3042277508
- 3045031090
- 3042371408
- 3039169594
- 3021599225
- 3039443706
- 3031980484
- 3026939957
- 3013481783
- 3030498909
- 3004135764
- 3033274371
- 3013995763
- 3038700878
- 3015283772
- 3033845665
- 3042254846
- 3016816791
- 3043126900
- 3022929665
- 3017961176
- 3035374320
- 3023237645
- 3028172072
- 3033883954
- 3010123655
- 3037609256
- 1055758
- 3017435733
- 3033847811
- 3014268427
- 3005581016
- 3015646995
- 3015195058
- 3017706553
- 3027303024
- 3043840133
- 3030338883
- 8010720
- 3007689716
- 3016915446
- 3019864920
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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