510(k) K061080
- Device
- IR PRO 250
- Applicant
- LHASA OMS, INC.
- 510(k) number
- K061080
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-14
- Date received
- 2006-04-18
- 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
- MARK W SHEEHAN
- Address
- 230 Libbey Pkwy. Weymouth MA US 02189 02189
FDA Registration Numbers#
- 3020977186
- 3034204485
- 3033511105
- 3005956028
- 3015646995
- 3010120748
- 3035371451
- 3020659203
- 3009656988
- 3013566770
- 3043661837
- 3042284335
- 3042277467
- 3014467408
- 3016002329
- 3010632563
- 3014139817
- 2087190
- 3015262665
- 3013178978
- 3015619571
- 3005515469
- 8043894
- 3028172072
- 3014159202
- 3010689958
- 3030979909
- 3027328721
- 3020311934
- 3020954225
- 3031595583
- 3015168585
- 3037609256
- 3014073090
- 3013069546
- 3021743553
- 3030412027
- 3043177693
- 3008756544
- 3030540470
- 3015924074
- 8022254
- 3004884150
- 3012512142
- 3033793026
- 3017150671
- 3012657194
- 3023876581
- 3017422691
- 3023344923
- 3015993373
- 3015989868
- 3015152461
- 3007167901
- 3033845665
- 3020978007
- 3009736547
- 3009765778
- 3024838204
- 3044596934
- 3045953413
- 3010627475
- 3013627744
- 3007689716
- 3013019295
- 3033850996
- 3043729119
- 3013374101
- 3044989687
- 3035785548
- 3045978226
- 3014290448
- 3010144038
- 3017618922
- 3022426824
- 3036780813
- 3038319732
- 3023229437
- 3044519321
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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