510(k) K091497
- Device
- K-LASER K-1200, MODEL 12 W
- Applicant
- ELTECH, S.R.L.
- 510(k) number
- K091497
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-08-19
- Date received
- 2009-05-20
- 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
- RICHARD ALBRIGHT
- Address
- 311 S. Royal Oaks Blvd. Suite 140-A Franklin TN US 37064 37064
FDA Registration Numbers#
- 3045925752
- 3012657194
- 3010894709
- 3044989687
- 3010280625
- 3030542040
- 3030498909
- 3009346095
- 1222993
- 3017248108
- 3017618900
- 3020237751
- 3021282471
- 3019734322
- 3020900954
- 3006475220
- 3027745834
- 3020491484
- 3016426850
- 3010120748
- 3029992391
- 3045031090
- 3016071154
- 3012430589
- 3010689958
- 3030412027
- 3012482375
- 3040314796
- 3030412417
- 3017419219
- 3013052700
- 3033920804
- 3004126239
- 3030234143
- 3042262476
- 3017140525
- 3016452327
- 3009736547
- 3016496662
- 3010055391
- 3018994966
- 3029338825
- 3011249646
- 3033274371
- 3010265883
- 3044921223
- 3011336685
- 3011644607
- 3029328624
- 3017153262
- 3023706404
- 3017422691
- 3005739661
- 3004884150
- 3015287734
- 3010053203
- 3021574099
- 3027328721
- 3015522128
- 3042261334
- 3023237645
- 8020802
- 3027200295
- 1066956
- 3006985163
- 3005972890
- 3015195058
- 3026668625
- 3020887108
- 2027755
- 3018070318
- 3023344923
- 3012184208
- 3042278063
- 3034286426
- 3011108368
- 3005515469
- 3005170249
- 3011506263
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#
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