FDA.report

SWL, Violet, labeled, US

Primary DI
B3926001000
Brand
SWL, Violet, labeled, US
Company
STELLAR LASERS LLC
Model
600100
Device description
The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promot
Published
2017-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications

CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions

SubmissionSupplement
K091158000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K091158000SCALAR WAVE LASER SYSTEMStellar Lasers2009-08-10ILY

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B3926001000PrimaryHIBCC0

GMDN Terms

TermDefinition
Musculoskeletal/physical therapy laser, home-useAn electrically-powered diode laser intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, rheumatism, disorders of the joints and soft/connective tissues), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a hand-held applicator designed for transcutaneous delivery of visible red/infrared laser light energy. It is intended to be operated by a healthcare provider in both a clinical setting and in the home.

Sterilization Methods

Method

Regulatory Flags

DUNS number
063416211
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B3926001100SWL, Silver, labeled, US6001102017-02-11
B3926001200Probe, 650 Red, labeled, US6001202017-02-11
B3926001300Probe, 780 IR, labeled, US6001302017-02-11
B3926001400Probe, 405 Blue-Vio, labeled, US6001402017-02-11

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