510(k) K152461
- Device
- The Time Machine Series Lasers
- Applicant
- MEDICAL LASERS MANUFACTURER INC.
- 510(k) number
- K152461
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-07-08
- Date received
- 2015-08-28
- 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
- BRUCE SCHOENGOOD
- Address
- 4400 Rte. 9 S., Suite 1000 Freehold NJ US 07728 07728
FDA Registration Numbers#
- 3043710338
- 3027509245
- 3014442295
- 3010280625
- 3010314781
- 2510425
- 3033530347
- 3020659203
- 3004126239
- 3005956028
- 1055758
- 3015283772
- 3021033331
- 3042278063
- 3010027944
- 3014601569
- 3012316249
- 3006416350
- 3015195058
- 3016099060
- 3043127589
- 3017103444
- 3017555752
- 3043503817
- 3034241144
- 3005327291
- 3030412027
- 3033850996
- 3016980707
- 3042284335
- 3014573304
- 3027745834
- 3045978226
- 3005515469
- 3023706404
- 3017125161
- 3015924074
- 3026038437
- 3014290448
- 3010265883
- 3033793026
- 3020954225
- 3020900954
- 3017207289
- 3008103948
- 3042277608
- 3016446653
- 3013596029
- 3010162243
- 3004264602
- 3005739661
- 3034745472
- 3016496662
- 3025421718
- 3013002868
- 3039443706
- 3042269047
- 2087190
- 3012799115
- 3013846070
- 3015139785
- 3039346136
- 3033845665
- 3034286426
- 3019577501
- 3011387816
- 3014977697
- 3017837510
- 3021282471
- 3007744197
- 3012446970
- 3044470839
- 9680222
- 3015783545
- 3005569927
- 3014171036
- 3033813891
- 3017422691
- 3033883954
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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