510(k) K042256
- Device
- IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE
- Applicant
- USA LASER BIOTECH INC.
- 510(k) number
- K042256
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-11-17
- Date received
- 2004-08-20
- 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
- M. JOYCE HEINRICH
- Address
- 12101 Cullen Blvd. # A Houston TX US 77047 77047
FDA Registration Numbers#
- 3004112621
- 3017618922
- 3014290448
- 3022553912
- 3014467408
- 3008539245
- 3042277640
- 3020659203
- 3023237645
- 3011654863
- 3017181358
- 3012512142
- 3005327291
- 3043138911
- 3031182687
- 3011765635
- 3044519321
- 3014073090
- 3022426824
- 3015619973
- 3033274371
- 3044596934
- 3016610172
- 3008959444
- 3017103444
- 3010689958
- 3046007041
- 3016750352
- 9615330
- 3042278987
- 3015456954
- 3043126851
- 3012125201
- 3010055391
- 2249769
- 3019015047
- 3013596029
- 2027755
- 3013057712
- 3014158749
- 3017961176
- 3020954225
- 3012262584
- 3008921662
- 3039169594
- 3043710338
- 3026322014
- 3004126239
- 3015974280
- 3016601021
- 3018126456
- 3004264602
- 3030358449
- 1222993
- 3031980484
- 3013374101
- 3013479807
- 3042371408
- 3017140525
- 3013019295
- 3015287734
- 2510425
- 3011387816
- 3008776882
- 3005972890
- 3012147801
- 9616086
- 3013178978
- 3033590685
- 3017264244
- 3017706553
- 3019778249
- 3029950834
- 3017419219
- 1528161
- 3008393409
- 1419489
- 3017248108
- 3012176966
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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