510(k) K091675
- Device
- LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER
- Applicant
- REIMERS AND JANSSEN GMBH
- 510(k) number
- K091675
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-15
- Date received
- 2009-06-09
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ASTRID SCHULZE
- Address
- Lessingstr. 79 Berlin DE 13158 13158
FDA Registration Numbers#
- 3019864920
- 8040537
- 3026038437
- 3029992391
- 3033850489
- 3010053203
- 2249769
- 3011877721
- 3039443708
- 3043126900
- 3027745834
- 3025936823
- 3015283772
- 3016099060
- 3023326918
- 3014442295
- 3021574099
- 3017152329
- 3006120071
- 3030541417
- 3004006265
- 3017618922
- 3035371451
- 3013019295
- 3017435733
- 3017207289
- 3036780813
- 3034609017
- 3042277640
- 3020887108
- 3040389697
- 3027645761
- 3027605507
- 3006555617
- 3026322014
- 3014296246
- 3030338883
- 3044905918
- 3011164092
- 3014159202
- 3016071154
- 3030542040
- 3017618900
- 3029633864
- 3015924074
- 3016879560
- 3021282523
- 3043089088
- 3010683450
- 3011387816
- 3030358449
- 1725006
- 3036675345
- 3024486937
- 3037013920
- 3033274371
- 1222993
- 1832894
- 3009142693
- 3005569927
- 3016214547
- 9613462
- 3024838204
- 3043138914
- 3003176094
- 3005327291
- 3017959252
- 3013995763
- 3030412027
- 3016915446
- 3018994966
- 3020954225
- 3010123655
- 3027327500
- 3011249646
- 3019623342
- 3033793026
- 3011066654
- 3018070318
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases