510(k) K091726
- Device
- NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980
- Applicant
- USA LASER BIOTECH INC.
- 510(k) number
- K091726
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-10-28
- Date received
- 2009-06-11
- 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
- JOYCE HEINRICH
- Address
- 12101 Cullen Blvd. # A Houston TX US 77047 77047
FDA Registration Numbers#
- 3005327291
- 3026668625
- 3017208137
- 3030498909
- 3004884150
- 9614977
- 3012386142
- 3015783545
- 3020659203
- 3043729119
- 3004642415
- 3043138914
- 3007278668
- 3021594370
- 3020900954
- 3038369467
- 3003725190
- 3042278063
- 3045031090
- 3006555617
- 3018126456
- 3021743553
- 3037031835
- 3045978226
- 3031182687
- 3037013920
- 3011258423
- 3009134668
- 3021033331
- 3019577501
- 3023348662
- 3044470839
- 3010120748
- 3033590685
- 3021282471
- 3017961176
- 3014726886
- 3040314796
- 3044921223
- 3010880718
- 3012125201
- 3014184914
- 3010632563
- 3033511105
- 3027645761
- 3014573304
- 3018949797
- 3015646995
- 3021386683
- 3008756544
- 3033883954
- 3015466811
- 1832894
- 3012176966
- 3044882985
- 3032062344
- 3034286426
- 3020491484
- 3017553373
- 3021599225
- 3020311934
- 3010360273
- 3024838204
- 3014290448
- 3009736547
- 3030508288
- 3017618900
- 2510425
- 3020954225
- 3014442295
- 3005730446
- 3042277508
- 3033450607
- 3027327500
- 3029992391
- 3044905918
- 3035879449
- 3015139785
- 9617486
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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