FDA.reportPublic FDA data

Acculite™  EndoOcular®

Primary DI
17290109140756
Brand
Acculite™  EndoOcular®
Company
LUMENIS INC.
Model
" Aspirat., 20ga 45° bend, SMA 906, 200µm"
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJMTransilluminator, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJMTransilluminator, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931072000HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBEHgm, Inc.1994-11-10HJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290109140756PackageGS110Not in Commercial Distribution
07290109140759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010914075617290109140756
07290109140759072901091407597290109140759

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
408-764-3000xxx@xxx.xxx

Regulatory Flags#

DUNS number
043618763
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109143248Novus SpectraNovus Spectra2016-08-24
07290109143279Novus SpectraDual Port2016-08-24
07290109143293Smart532Smart5322016-10-10
07290109143316Selecta DuetSelecta Duet2016-08-25
07290109140612Smart LIONA2023-06-14
07290109143835Smart LIONA2023-06-14
07290109143842Smart LIONA2023-06-14
07290109143637Smart-V Illumination Add-onSmart-V Illumination Add-on2022-03-23
07290109145181Digital DuetSelecta Duet Digital2021-03-22
07290109143255Selecta DuetSelecta Duet2016-08-24
07290109143262LaserLink SLaserLink S2016-08-25
07290109143286Vision OneVision One2016-08-25
07290109143309Selecta DuetSelecta Duet2016-08-16
07290109143378LIO KeelerLIO Keeler2016-09-11
07290109143385LaserLink ZLaserLink Z2016-08-31
07290109143392LaserLink ZLaserLink Z2016-08-31
07290109143446Automatic Eye Safety FilterAutomatic Eye Safety Filter2016-09-27
07290109143491LaserLink HSLaserLink HS2016-08-31
07290109143507Fixed Eye Safety FilterFixed Eye Safety Filter2016-11-27
07290109143545Array LaserLinkArray LaserLink2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053755202973FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJM2025-07-17
00810123483167Vortex Surgical Inc.Vortex Surgical, Inc.HJM2025-04-18
00810123483150Vortex Surgical Inc.Vortex Surgical, Inc.HJM2025-04-18
0063230700235925GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
0063230700236627GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
0063230700237323GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
1063230700235625GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
1063230700236327GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
1063230700237023GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
04053755119943OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJM2022-12-21
04053755120109OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJM2022-12-21
04053755200429FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJM2022-12-21
04053755199679WALL TRANSFORMER EN 200Heine Optotechnik GmbH & Co. KGHJM2022-12-12
04053755199686WALL TRANSFORMER EN 200-1Heine Optotechnik GmbH & Co. KGHJM2022-12-12
10812594013079NeoGlo® DisposableNeotech Products LLCHJM2021-05-20
10812594013086NeoGlo® DisposableNeotech Products LLCHJM2021-05-20
00812594013072NeoGlo DisposableNEOTECH PRODUCTS, INC.HJM2021-05-20
00812594013089NeoGlo DisposableNEOTECH PRODUCTS, INC.HJM2021-05-20
10841305112138SynergeticsSYNERGETICS USA, INC.HJM2020-05-31
20841305112142SynergeticsSYNERGETICS USA, INC.HJM2020-05-31
07290109140766Acculite™ EndoOcular®LUMENIS INC.HJM2016-09-25
17290109140763Acculite™  EndoOcular®LUMENIS INC.HJM2016-09-25
B396050080VT0ESIFTT MEDICAL, INC.HJM2016-09-16
B396050100VT0ESIFTT MEDICAL, INC.HJM2016-09-16
B3960501020ESIFTT MEDICAL, INC.HJM2016-09-16
B3960501120ESIFTT MEDICAL, INC.HJM2016-09-16
B396MSK1116050ESIFTT MEDICAL, INC.HJM2016-09-16
07290109140759Acculite™ EndoOcular®LUMENIS INC.HJM2016-09-12
05055272707794Finhoff Transilluminator 2.8vKEELER LIMITEDHJM2016-08-16
05055272715140Transilluminator 3.5v in cartonKEELER LIMITEDHJM2016-08-16