510(k) K060134
- Device
- APOLLO IR HEAT LAMP SYSTEM
- Applicant
- APOLLO PHYSICAL THERAPY PRODUCTS INTERNATIONAL
- 510(k) number
- K060134
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-03-21
- Date received
- 2006-01-18
- 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
- M. JOYCE HEINRICH
- Address
- 12101 Cullen Blvd. Suite A Houston TX US 77047 77047
FDA Registration Numbers#
- 3027200295
- 3038620598
- 3027327500
- 3039435282
- 3010205626
- 3016986320
- 3017103444
- 3012512142
- 3015139785
- 3007689716
- 3012799115
- 3014073090
- 3010055391
- 3012147801
- 3010120748
- 3004505220
- 3020887108
- 3043165979
- 3043177693
- 3010683450
- 3015522128
- 3016071154
- 3033848228
- 3031980484
- 3044882985
- 3045954069
- 3021283084
- 3006978331
- 3017422691
- 3011765635
- 1066956
- 3020978007
- 3018608545
- 3015619571
- 3026038437
- 3031944951
- 3037609256
- 3004006265
- 3034609017
- 3042284335
- 3038319732
- 3003725190
- 3011539161
- 3030508288
- 3043713503
- 3016610172
- 1000548922
- 3012125201
- 3017207289
- 3043709770
- 3006416350
- 3045925752
- 3015262665
- 3030540470
- 3013479807
- 3016980707
- 3013057712
- 3033847811
- 3021743553
- 3017415521
- 3003082988
- 3018994966
- 3011108368
- 3033850996
- 3007674911
- 3016171836
- 3025358939
- 3017199264
- 3009973354
- 3043127589
- 3013510252
- 3014545271
- 3033590685
- 3035374295
- 3018070318
- 3021282471
- 3006120071
- 9617486
- 1055581
- 9680934
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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