510(k) K080102
- Device
- TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM
- Applicant
- ESCADA INTERNATIONAL, INC.
- 510(k) number
- K080102
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-08-20
- Date received
- 2008-01-14
- Regulation
- 890.5500
- Classification name
- Lamp, Infrared, Therapeutic Heating
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kevin Walls
- Address
- 13 Red Fox Ln. Littleton CO US 80127 80127
FDA Registration Numbers#
- 3014467408
- 3004027973
- 3021282523
- 3011249646
- 3037013920
- 3015529593
- 3012776156
- 3010360273
- 3042277467
- 3013510252
- 3004724437
- 3018126456
- 3044470839
- 3009134668
- 3008921662
- 3012125201
- 3007744197
- 3031191551
- 3030151584
- 3011539161
- 3012512142
- 3004884150
- 3012799115
- 3012316249
- 3034609017
- 3016426850
- 3043503817
- 3017124433
- 3019623342
- 3015466811
- 3001224205
- 3016610172
- 3012482375
- 3017150671
- 3010894709
- 3043127589
- 3023876581
- 2249769
- 3019577501
- 3016879560
- 3038319732
- 3011644607
- 3013121972
- 3013069546
- 3035878914
- 3033850489
- 3007608780
- 3030358449
- 3044596934
- 1832894
- 3003176094
- 3016915446
- 3031944951
- 3024838204
- 3010162243
- 3040389697
- 3030926983
- 3038620598
- 3006120071
- 3010730876
- 3011387816
- 3010627475
- 3004135764
- 9680934
- 3032062344
- 3012541016
- 3017207289
- 3017248108
- 3043729119
- 3021743553
- 3030708724
- 3010703418
- 3004642415
- 3014737458
- 3015993373
- 3020311934
- 3020887108
- 3009765778
- 3019778249
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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