FDA.reportPublic FDA data

R11 Air

Primary DI
04260489020425
Brand
R11 Air
Company
KBL GmbH
Model
R11-s-2848r1-1188i1 UP 12
Device description
Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain indications.
Published
2025-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating
OLIFat Reducing Low Level Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
OLIFat Reducing Low Level LaserGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202955000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202955000Contour Light CL-100Contour Research, LLC2021-05-19OLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260489020425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260489020425042604890204254260489020425

GMDN Terms#

Term, Definition table
TermDefinition
Red/infrared light phototherapy unitAn electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341936227
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260489020418KBL K11 Air (Loft)K11-s-2010A-552B UP 052024-05-15
04260489020401KBL K9S vitaSunK9S-v-52-9s-2s UP cpi 052024-03-07
04260489020357KBL K5 pureSunK5-p-38-3Hp-0 UP ep 052023-06-09
04260489020364KBL K5 extraSunK5-e-38-3HP-0 UP ep 052023-06-09
04260489020371KBL K5 hybridSunK5-h-38-3Hp-0 UP ep 052023-06-09
04260489020388KBL K9S extraSunK9S-e-52-9s-2s UP cpi 052023-06-09
04260489020395KBL K9S hybridSunK9S-h-52-9s-2s UP cpi 052023-06-09
04260489020289KBL K7 extraSunK7-e-46-4HP-2s UP cpi 052022-12-20
04260489020296KBL K7 pureSunK7-p-46-4Hp-2s UP ep 052022-12-20
04260489020302KBL K7 pureSunK7-p-46-4Hp-2s UP cpi 052022-12-20
04260489020319KBL K7 pureSunK7-p-46-4Hp-0 UP ep 052022-12-20
04260489020326KBL K7 hybridSunK7-h-46-4Hp-2s UP cpi 052022-12-20
04260489020333KBL K7S extraSunK7S-e-46-4s-2s UP cpi 052022-12-20
04260489020340KBL K7S hybridSunK7S-h-46-4s-2s UP cpi 052022-12-20
04260489020227KBL Tower Space 3000 hybridSunT3/52-1802021-08-17
04260489020173KBL 8000 alpha extraSun+KBL 7908 - 50-6T12/4g 1616 int us (T)2021-08-02
04260489020241KBL 7900 alpha extraSun+KBL 7908 - 50-6T12/4g 1616 int us2021-08-02
04260489020258KBL 7000 alpha extraSun+KBL 6808 - 46-6T12/4g 1616 int us (T)2021-08-02
04260489020265KBL 5600 alpha extraSun+KBL 5600 - 42-2T12/4a - 1616 cpi u_us2021-08-02
04260489020272KBL 6800 alpha extraSun+KBL 6808 - 46-6T12/4g 1616 int us2021-08-02

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Primary DI, Brand, Company table
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