FDA.reportPublic FDA data

Lollipop Probe

Primary DI
05060494130541
Brand
Lollipop Probe
Company
THOR PHOTOMEDICINE LIMITED
Model
2.3
Device description
S2197 Lollipop Probe
Published
2021-05-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033923000TH0R DDII IR LAMP SYSTEMThor Intl.2004-03-17ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060494130541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060494130541050604941305415060494130541

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, line-poweredA mains electricity (AC-powered) device designed to emit a low-level narrow-band (LLNB) red light in the visible and invisible wavelength around 600-940 nm, with the intent to modify cellular metabolism and/or improve blood flow through increased vasodilation primarily for the accelerated healing of cutaneous or mucosal wounds and/or to provide pain relief. It can be used in a healthcare facility and in the home. It may be used to help treat skin ulcers, acne, herpes simplex lesions, and postoperative wounds, or to relieve pain associated with inflammatory processes such as rheumatoid arthritis (RA) or lower back injury.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
856233908
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060494130664NIR Acutip Laser32026-05-07
05060494130671Trigger Point Laser32026-05-07
05060494130688Red Acutip Laser32026-05-07
05060494130695Red Laser22026-05-07
05060494130701Laser Cluster22026-05-07
05060494130718Giant Laser Cluster32026-05-07
05060494130725Large LED Cluster32026-05-07
05060494130732Medium LED Cluster32026-05-07
05060494130749Small LED Cluster32026-05-07
05060494130756Trigger Point Handpiece22026-05-07
0506049413063369 LED Cluster issue 332025-07-31
0506049413064019 LED Cluster issue 332025-07-31
05060494130657104 LED Cluster issue 332025-07-31
05060494130619810nm 200mW NIR Light Guide Laser2.02025-07-15
05060494130626660nm 75mW Red Light Guide Laser1.02025-07-15
05060494130589LED Helmet2.32021-10-06
05060494130596LED Helmet PRX2.32021-10-06
05060494130572LED Lollipop2.32021-10-01
05060494130558810nm 16W Cluster PRX100 (80x200mW)2.32021-05-17
05060494130565PRX Lollipop Probe2.32021-05-17

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