510(k) K080689
- Device
- SPECTRA THERAPY SYSTEM A1000 LASER DEVICE
- Applicant
- PREMIER DYNAMICS, INC.
- 510(k) number
- K080689
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-07-09
- Date received
- 2008-03-11
- 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
- JOHN J STEPHAN
- Address
- 3863 Rochester Rd. Troy MI US 48083 48083
FDA Registration Numbers#
- 3045978226
- 3005581016
- 3033274371
- 3008395118
- 3018994966
- 3018949797
- 3007278668
- 3030412027
- 3025936823
- 3017905264
- 3035371451
- 3009765778
- 3020900954
- 3010894709
- 3011258423
- 3014680784
- 3014577013
- 3014527699
- 3014467408
- 3030979909
- 3016750352
- 3038369467
- 3017649333
- 3006985163
- 3035374295
- 3010055391
- 3029338825
- 3017103444
- 3010703418
- 3023237645
- 3020311934
- 1222993
- 3024838204
- 3007744197
- 9680222
- 3030648305
- 1055581
- 3021482081
- 3017207289
- 3004126239
- 3039435282
- 3017125161
- 3022553912
- 3025358939
- 3023706404
- 3017618900
- 3004264602
- 3028172072
- 3021282471
- 3012541016
- 3013121972
- 3006475220
- 3015262665
- 3012316249
- 3007674911
- 3004006265
- 3014184914
- 3015139785
- 3043709874
- 3030708724
- 3018126456
- 3043127589
- 3015646995
- 3010162243
- 3045925752
- 3019577501
- 3012446970
- 3033847811
- 3031075901
- 3014268427
- 3003889343
- 3043840133
- 3013846070
- 3014290448
- 3004505220
- 3040314796
- 3037031835
- 3003082988
- 3033511105
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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