510(k) K033768
- Device
- ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE
- Applicant
- ALTUS MEDICAL, INC.
- 510(k) number
- K033768
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-02-17
- Date received
- 2003-12-03
- 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
- Yes
Applicant Contact#
- Contact
- KATHY MAYNOR
- Address
- 821 Cowan Rd. Burlingame CA US 94010 94010
FDA Registration Numbers#
- 3027509245
- 3021482081
- 3012482375
- 9613462
- 3009142693
- 3010703418
- 3020491484
- 3033511105
- 3043503817
- 3012430589
- 3011670002
- 3004264602
- 3016750352
- 3017419219
- 3016171836
- 3037609256
- 3013479807
- 3017961176
- 3018608545
- 3029338825
- 3044596934
- 3015287734
- 3010144038
- 3008103948
- 2954354
- 3017415521
- 9616086
- 3016446653
- 3013566770
- 3015262665
- 3042262476
- 3001431138
- 3034204485
- 3039346136
- 3012512142
- 3035186104
- 3014296246
- 3045031090
- 3021283084
- 3018126456
- 3006190476
- 3008959444
- 3012799115
- 3040389697
- 3004135764
- 3031595583
- 3034241144
- 3016915446
- 3043661837
- 3006120071
- 3014527699
- 3016055197
- 3012446970
- 1225072
- 3011077581
- 3017618900
- 3023371360
- 3030338883
- 3008592814
- 3019778249
- 3016610172
- 3042371408
- 3043709770
- 3012125201
- 3027745834
- 3006849751
- 3003015433
- 3031182687
- 3015456954
- 3017706553
- 3017422691
- 3027303024
- 3046005921
- 3012184208
- 3012725363
- 3029992391
- 3035878914
- 3018188770
- 3022553912
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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