FDA.reportPublic FDA data

LumenEye X1 Scope

Primary DI
05060768280286
Brand
LumenEye X1 Scope
Company
SURGEASE INNOVATIONS LIMITED
Model
LX1-SCP-203
Catalog number
LX1-SCP-203
Device description
A portable digital rectoscope enabling rapid, real-time colorectal diagnosis.
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FANSigmoidoscope, Rigid, Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FANSigmoidoscope, Rigid, ElectricalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232262000LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )Surgease Innovations Limited2023-11-30FAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060768280286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060768280286050607682802865060768280286

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical rectoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during rectoscopy. Anatomical images are transmitted to the user typically through relayed lens optics. This device is longer than a proctoscope to provide a deeper view and it is typically equipped with illumination in the distal end. It is typically used to examine the structures of the rectum for irregularities. This is a reusable device.

Regulatory Flags#

DUNS number
221628713
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060768280040Consumable Pack (Sheath, Obturator, Manifold & Camera Cover)LX1-CCS-202LX1-CCS-2022026-05-13
05060768280231Consumable Pack (Sheath, Obturator & Manifold)LX1-CSB-201LX1-CSB-2012026-05-13
05060768280736Large LumenEye x1 Manifold -26mm LX1-LMB-261LX1-LMB-2612026-05-13
05060768280750Large LumenEye x1 Manifold -30mm LX1-LMB-301LX1-LMB-3012026-05-13
05060768280576SESISSIS-CSB-1012026-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060768280040Consumable Pack (Sheath, Obturator, Manifold & Camera Cover)SURGEASE INNOVATIONS LIMITEDFAN2026-05-13
05060768280231Consumable Pack (Sheath, Obturator & Manifold)SURGEASE INNOVATIONS LIMITEDFAN2026-05-13
05060768280736Large LumenEye x1 Manifold -26mm SURGEASE INNOVATIONS LIMITEDFAN2026-05-13
05060768280750Large LumenEye x1 Manifold -30mm SURGEASE INNOVATIONS LIMITEDFAN2026-05-13