FDA.reportPublic FDA data

ClearSpec

Primary DI
20860008900368
Brand
ClearSpec
Company
Clearspec LLC
Model
105
Catalog number
105
Device description
ClearSpec LED Speculum Illuminator - case
Published
2025-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130046000CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLC2013-08-06HIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860008900368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086000890036820860008900368

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal illuminatorA device used to illuminate the vagina during a gynaecological examination or procedure. It is typically a chemiluminescent illumination source that is attached to the upper dilator blade of a vaginal speculum. This is a single-use device.

Regulatory Flags#

DUNS number
075061406
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860008900309ClearSpec1021022025-10-29
10860008900316ClearSpec1031032025-10-29
10860008900323ClearSpec1041042025-10-29
10860008900330ClearSpec102NS102NS2025-10-29
10860008900347ClearSpec103NS103NS2025-10-29
10860008900354ClearSpec104NS104NS2025-10-29
10860008900361ClearSpec1051052025-10-29
00860008900302ClearSpec1021022025-10-29
00860008900319ClearSpec1031032025-10-29
00860008900326ClearSpec1041042025-10-29
00860008900333ClearSpec102NS102NS2025-10-29
00860008900340ClearSpec103NS103NS2025-10-29
00860008900357ClearSpec104NS104NS2025-10-29
00860008900364ClearSpec1051052025-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
B366LED0204R00PORTALEDEclerisKYT2026-02-11
B366LED0204PORTALEDEclerisKYT2026-01-23
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
B366LED0203PORTALEDEclerisKYT2025-11-21
10860008900361ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
00714646001375Rechargeable Light SourceBionix, LLCKYT2025-02-25
07290016672756TytoProTYTO CARE LTDKYT2024-05-26
07290016672763TytoHomeTYTO CARE LTDKYT2024-05-26
04053755201617DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
04053755201655DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
00811331011654TruBrite Adhesive Retractor LightTz Medical, Inc.KYT2023-10-20
00816835024254IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024261IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024278IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024285IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024292IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00810132041792HCSConcordance Healthcare Solutions LLCKYT2023-07-28
00810114912010SurgiTelSurgitelKYT2023-01-12
00810114912027SurgiTelSurgitelKYT2023-01-12
00810114912034SurgiTelSurgitelKYT2023-01-12
00810114912041SurgiTelSurgitelKYT2023-01-12
00810114912058SurgiTelSurgitelKYT2023-01-12
00810114912065SurgiTelSurgitelKYT2023-01-12
00634782099480Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099497Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099503Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099510Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099527Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11