510(k) K080786
- Device
- ML830TP
- Applicant
- MICROLIGHT CORPORATION OF AMERICA
- 510(k) number
- K080786
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-10-03
- Date received
- 2008-03-20
- 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
- FRED A SIMPSON
- Address
- 2935 Highland Lakes Dr. Missouri City TX US 77459 77459
FDA Registration Numbers#
- 3012147801
- 3011654863
- 3018070318
- 3011249646
- 3014073090
- 3005956028
- 3020954225
- 3002824588
- 3016610172
- 3012725363
- 3010120748
- 3025104654
- 3008921662
- 3030151584
- 3017419219
- 3013481783
- 3033920804
- 3035374386
- 3009323672
- 3035785548
- 3045031090
- 3015619571
- 3034609017
- 3030358449
- 3027328721
- 3044921223
- 3045978226
- 3015168585
- 3015783545
- 3008776882
- 3014268427
- 3015338588
- 3006849751
- 3017207289
- 3043089088
- 3015974280
- 3014601569
- 3016980707
- 3009765778
- 3017153262
- 3015152461
- 3014737458
- 3016214547
- 3005170249
- 3027605507
- 3029338825
- 2013558
- 3038620598
- 3043713503
- 3017264244
- 3016453096
- 3035371451
- 3010144038
- 3016055197
- 3043177693
- 3011877721
- 3010123655
- 3008395118
- 3033845665
- 3003895865
- 1721293
- 3017236146
- 3005730446
- 3004505220
- 9614977
- 3015287734
- 3005972890
- 3007165178
- 9616086
- 3011387816
- 3003889343
- 3006978331
- 3030648305
- 3016879560
- 3013846070
- 3012386142
- 3023808059
- 3004006265
- 3034288049
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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