FDA.reportPublic FDA data

Amoils Epithelial Scrubber

Primary DI
00628693343237
Brand
Amoils Epithelial Scrubber
Company
Innovative Excimer Solutions
Model
Amoils Power Handle
Catalog number
AM3DMHANDLE
Device description
Amoils Power Handle
Published
2025-02-28
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
HOGBurr, Corneal, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOGBurr, Corneal, Battery-PoweredOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962989000AMOILS EPITHELIAL SCRUBBERS. Percy Amoils1997-01-09HOG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628693343237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628693343237006286933432376286933432370628693343237

GMDN Terms#

Term, Definition table
TermDefinition
Corneal bur system, battery-poweredAn assembly of devices designed for abrasion of the cornea and other eye tissues. It typically consists of a small, battery-powered rotatory handpiece with a motor, and a small shaft made of a hard metal such as steel (i.e., a bur) that may include a diamond sphere at its tip. The system is used in procedures such as the gentle removal ("brushing") of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object, abrasion of the cornea to polish corneal scratches or the pterygium bed after surgical removal, and/or abrasion of lid margin lesions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
249464702
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628693343244Amoils Epithelial ScrubberAmoils Neck MountAM3DMNECK2025-02-28
00628693343251Amoils Epithelial ScrubberAmoils Handle Charger (120V)AM3DM120V2025-02-28
00628693343268Amoils Epithelial ScrubberAmoils Handle Charger (230V)AM3DM230V2025-02-28
00628693343091Amoils Epithelial ScrubberAmoils Power Handle, Neck & Charger - Kit (120V)AM1EXPH02024-10-31
00628693343107Amoils Epithelial ScrubberAmoils Power Handle, Neck & Charger - Kit (230V)AM1EXPH12024-10-31
00628693343039Amoils Epithelial Scrubber Myopic Pack of 25AM1EX-MYOPICx2022-12-01
00628693343046Amoils Epithelial Scrubber Hyperopic Pack of 25AM1EX-HYPx2022-12-01
00628693343053Amoils Epithelial Scrubber Hyperopic XL Pack of 25AM1EX-HXLx2022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628693343244Amoils Epithelial ScrubberInnovative Excimer SolutionsHOG2025-02-28
00628693343251Amoils Epithelial ScrubberInnovative Excimer SolutionsHOG2025-02-28
00628693343268Amoils Epithelial ScrubberInnovative Excimer SolutionsHOG2025-02-28
00628693343091Amoils Epithelial ScrubberInnovative Excimer SolutionsHOG2024-10-31
00628693343107Amoils Epithelial ScrubberInnovative Excimer SolutionsHOG2024-10-31
10887482177522BovieASPEN SURGICAL PRODUCTS, INC.HOG2024-08-28
10887482177546BovieASPEN SURGICAL PRODUCTS, INC.HOG2024-08-28
00887482177532BovieSYMMETRY SURGICAL INC.HOG2024-08-28
00887482177556BovieSYMMETRY SURGICAL INC.HOG2024-08-28
00887482176795BovieASPEN SURGICAL PRODUCTS, INC.HOG2024-08-27
00628693343039Amoils Epithelial Scrubber Innovative Excimer SolutionsHOG2022-12-01
00628693343046Amoils Epithelial Scrubber Innovative Excimer SolutionsHOG2022-12-01
00628693343053Amoils Epithelial Scrubber Innovative Excimer SolutionsHOG2022-12-01
00841668120057BurrKATENA PRODUCTS, INC.HOG2022-11-16
00841668120064BurrKATENA PRODUCTS, INC.HOG2022-11-16
30886158010037Ophtho-Burr®Beaver-Visitec International, Inc.HOG2022-01-19
00886158010012Ophtho-Burr®Beaver-Visitec International, Inc.HOG2022-01-19
00886158010029Ophtho-Burr®Beaver-Visitec International, Inc.HOG2022-01-19
00886158010043Ophtho-Burr®Beaver-Visitec International, Inc.HOG2022-01-19
00886158010036Ophtho-Burr®Beaver-Visitec International, Inc.HOG2022-01-19
00841668113103BurrKATENA PRODUCTS, INC.HOG2020-09-14
00841668113110BurrKATENA PRODUCTS, INC.HOG2020-09-14
00841668113127BurrKATENA PRODUCTS, INC.HOG2020-09-14
00841668113141BurrKATENA PRODUCTS, INC.HOG2020-09-14
00841668113158BurrKATENA PRODUCTS, INC.HOG2020-09-14
00841668113165BurrKATENA PRODUCTS, INC.HOG2020-09-14
00192896093805ALGERBRUSH HANDLESONTEC INSTRUMENTS, INC.HOG2019-03-11
00192896012615ALGERBRUSH II CORNEAL RUST RING REMOVERSONTEC INSTRUMENTS, INC.HOG2018-09-18
00192896012622ALGERBRUSH II CORNEAL RUST RING REMOVERSONTEC INSTRUMENTS, INC.HOG2018-09-18
00192896012646ALGERBRUSH DIAMOND FINE GRIT BURRSONTEC INSTRUMENTS, INC.HOG2018-09-18