FDA.reportPublic FDA data

PENTAX

Primary DI
04961333216864
Brand
PENTAX
Company
HOYA CORPORATION
Model
OL-X29
Device description
PENTAX Lamp Cartridge With Lamp OL-X29
Published
2023-07-31
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
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150618000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150618000PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc.2015-11-24PEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333216864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333216864049613332168644961333216864

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, line-poweredA mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
691519705
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333227747PENTAXBS-LC12017-04-07
04961333228362PENTAXEG-3670URK2017-04-07
04961333228409PENTAXEG-3870UTK2017-04-07
04961333233793PENTAXEG-3270UK2018-08-10
04961333254316PENTAXEC-2990Li2024-07-26
04961333254323PENTAXEC34-i10L2024-07-26
04961333254330PENTAXEC-3890TLK2024-07-26
04961333254347PENTAXEC38-i10L2024-07-26
04961333254354PENTAXEC-3890Li2024-07-26
04961333254385PENTAXEG-2490K2024-07-26
04961333254392PENTAXEG27-i102024-07-26
04961333254408PENTAXEG-2990i2024-07-26
04961333254422PENTAXEG29-i102024-07-26
04961333254439PENTAXEG-3890TK2024-07-26
04961333255238VIVIDEOCP-10002025-12-19
04961333255306VIVIDEOVNL9-CP2025-12-19
04961333255191VIVIDEOCP-10002025-12-19
04961333255245VIVIDEOVNL9-CP2025-12-19
04961333254620PENTAX MedicalOE-B172024-12-13
04961333077731PENTAXOF-B1612023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04961333255801INSPIRAHOYA CORPORATIONPEA2025-06-20
04961333255825INSPIRAHOYA CORPORATIONPEA2025-06-20
04961333255818INSPIRAHOYA CORPORATIONPEA2025-06-20
04961333255832INSPIRAHOYA CORPORATIONPEA2025-06-20
04547410513790FUJIFILMFUJIFILM CORPORATIONPEA2025-05-31
04961333251605PENTAX MedicalHOYA CORPORATIONPEA2024-05-14
04961333251636PENTAX MedicalHOYA CORPORATIONPEA2024-05-14
04961333251049PENTAX MedicalHOYA CORPORATIONPEA2024-03-11
04961333251025PENTAX MedicalHOYA CORPORATIONPEA2024-03-11
04961333254910INSPIRAHOYA CORPORATIONPEA2023-12-01
04961333254934INSPIRAHOYA CORPORATIONPEA2023-12-01
04961333249183DEFINAHOYA CORPORATIONPEA2023-10-31
04961333249176DEFINAHOYA CORPORATIONPEA2023-10-31
04961333251650PENTAX MedicalHOYA CORPORATIONPEA2023-10-31
04961333252145PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252169PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251827PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251834PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251841PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252107PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252114PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251858INSPIRAHOYA CORPORATIONPEA2023-09-20
04961333251896INSPIRAHOYA CORPORATIONPEA2023-09-20
04961333247974INSPIRAHOYA CORPORATIONPEA2023-09-16
04961333247929INSPIRAHOYA CORPORATIONPEA2023-09-16
04961333075157PENTAXHOYA CORPORATIONPEA2023-09-15
04961333247462PENTAX MedicalHOYA CORPORATIONPEA2023-09-15
04961333132607PENTAXHOYA CORPORATIONPEA2023-08-18
04961333070367PENTAXHOYA CORPORATIONPEA2023-07-31
04961333075164PENTAXHOYA CORPORATIONPEA2023-07-31