FDA.report

510(k) K091158

Device
SCALAR WAVE LASER SYSTEM
Applicant
STELLAR LASERS
510(k) number
K091158
Product code
ILY  
Decision
Substantially Equivalent (SESE)
Decision date
2009-08-10
Date received
2009-04-21
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

Related Records

Applicant Contact

Contact
Kevin Walls
Address
5401 S Cottonwood Ct. Greenwood Village CO US 80121 80121

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Related GUDID Devices

Primary DIBrandCompanyPublished
B3926001400Probe, 405 Blue-Vio, labeled, USSTELLAR LASERS LLC2017-02-11
B3926001300Probe, 780 IR, labeled, USSTELLAR LASERS LLC2017-02-11
B3926001200Probe, 650 Red, labeled, USSTELLAR LASERS LLC2017-02-11
B3926001100SWL, Silver, labeled, USSTELLAR LASERS LLC2017-02-11
B3926001000SWL, Violet, labeled, USSTELLAR LASERS LLC2017-02-11

Other 510(k) Records For Product Code ILY  

510(k)DeviceApplicantDecision date
K253965CureLight 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
K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company , Ltd.2025-05-19
K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc.2024-10-15
K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V.2023-03-09
K221189OLIZ LTB-1000ALtbio Co., Ltd.2022-08-29
K213524CytonPro-5000Cytonsys, Inc.2022-08-10
K202028dermalux Flex MDAesthetic Technology, Ltd.2020-12-16
K171087AXON IR Heat LampCrystal Medtech, LLC2017-07-07
K163079HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy SystemHealthlight, LLC2017-06-13
K170068Softcure 96Wellray Medical Laser, Inc.2017-05-05
K162590Bashan TDP Heat LampChogqing Yuhe Medical Instruments Co., Ltd.2017-02-14
K162763Vevazz LED Heat LampVevazz, LLC2017-01-05
K160849WS(TM) Far-Infrared Therapy Unit, Model KP-B210Ws Far IR Medical Technology Co., Ltd.2016-12-15
K152087HeatLux Pro IIHome Skinovations , Ltd.2016-07-29
K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.2016-07-26

Legacy Summary

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FDA Review

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