510(k) K134017
- Device
- GIGALASER
- Applicant
- POWERMEDIC APS
- 510(k) number
- K134017
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-02
- Date received
- 2013-12-30
- 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. Suite A Houston TX US 77047 77047
FDA Registration Numbers#
- 3018317166
- 3016214547
- 3003015433
- 3029992391
- 3016002329
- 3017619615
- 3022553912
- 3012588399
- 3020221089
- 3019864920
- 3015152461
- 3017207289
- 3029328624
- 3011506263
- 3004884150
- 9680934
- 3016452327
- 3027745834
- 3016171836
- 3017181358
- 3012482375
- 3016879560
- 9680222
- 3016071154
- 3019778249
- 3021283084
- 3010144038
- 3016610172
- 3007744197
- 3030234143
- 3013178978
- 3023339107
- 3013057712
- 3016019469
- 3040389697
- 3015262665
- 3026312077
- 3006984716
- 3003654318
- 3046005906
- 3026668625
- 3042371408
- 3030648305
- 3020977186
- 3012316249
- 3015283772
- 3018188770
- 3018123168
- 3043709770
- 3006978331
- 3045953413
- 3042865685
- 3017103444
- 3025358939
- 3003082988
- 3042278987
- 3027509245
- 3026322014
- 3016099060
- 3011077581
- 3030412417
- 3040389273
- 3011249646
- 3004139830
- 3010894709
- 3020887108
- 3043840133
- 3025421718
- 3011539161
- 3033883954
- 3006849751
- 3001431138
- 3014680784
- 3015993373
- 8022254
- 3027263493
- 3038622006
- 3020900954
- 3027328721
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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