FDA.report

78D Cielo

Primary DI
00811608018652
Brand
78D Cielo
Company
VOLK OPTICAL INC.
Model
C78
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HJLLens, Condensing, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
HJLLens, Condensing, DiagnosticOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811608018652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811608018652008116080186528116080186520811608018652

GMDN Terms

TermDefinition
Diagnostic condensing lensAn ophthalmic lens used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) to focus reflected light from the fundus of the eye. Compared to direct ophthalmosocoy, the indirect method enables better viewing of the peripheral region of the fundus out to the ora serrata (serrated junction between the retina and the ciliary body).

Sterilization Methods

Method

Contacts

PhoneEmail
440-942-6161snigdha.katragadda@volk.com

Regulatory Flags

DUNS number
071125835
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10811608019915Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD)VSGSBD2026-02-04
10811608019922Single Use GonioPro Surgical Lens + Single-Port Stabilizer (VSGLSAD)VSGLSAD2026-02-04
10811608019939Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD)VSGLSBD2026-02-04
10811608019946Single Use GonioPro Surgical Lens + Handle (VSGLHD)VSGLHD2026-02-04
00811608019802Rapid SLTVLUMSLT2025-08-07
0081160801981920D Limited Edition #2V20LC-LE22025-08-01
0081160801982628D Limited Edition #2V28LC-LE22025-08-01
00811608019833Pan Retinal 2.2 Limited Edition #2VPRC-LE22025-08-01
0081160801984078D Limited Edition #2V78C-LE22025-08-01
0081160801985790D Limited Edition #2V90C-LE22025-08-01
00811608019864Super 66® Limited Edition #2VS66-LE22025-08-01
00811608019871SuperField® Limited Edition #2VSFNC-LE22025-08-01
00811608019888Digital Wide Field® Limited Edition #2VDGTLWF-LE22025-08-01
00811608019376Mounting Kit, Topcon OMS-800121622025-06-30
00811608019796Mounting Kit, MediWorks SM621126552025-06-30
00811608019765Mounting Kit, Alcon Revalia126402025-03-26
00811608019772Mounting Kit, Takagi OM-9126452025-03-26
00811608019789Mounting Kit, Takagi OM-19126502025-03-26

Other Devices Sharing Product Codes

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0081160801981920D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
0081160801982628D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019833Pan Retinal 2.2 Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
0081160801984078D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
0081160801985790D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019864Super 66® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019871SuperField® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019888Digital Wide Field® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
0081160801476020D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801477728D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014784Pan Retinal 2.2 Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014791Digital ClearField Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801480778D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801481490D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014821Super 66® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014838SuperField® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014845Digital Wide Field® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014852Digital High Mag® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
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00841668144275Primary Lens Set, 28D, 90D, 4 MirrorKATENA PRODUCTS, INC.HJL2024-04-11
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00850054345028SurgiView 20DIon Vision, IncHJL2023-08-23
00850054345035eZView 90DIon Vision, IncHJL2023-08-23
00850054345042eZView 78DIon Vision, IncHJL2023-08-23
00850054345059eZView 60DIon Vision, IncHJL2023-08-23
00850054345066eZView 15DIon Vision, IncHJL2023-08-23
00850054345073eZView 25DIon Vision, IncHJL2023-08-23
00850054345080eZView 28DIon Vision, IncHJL2023-08-23
00850054345097SurgiView 28DIon Vision, IncHJL2023-08-23