FDA.reportPublic FDA data

DELTA 30 PRO

Primary DI
04053755201617
Brand
DELTA 30 PRO
Company
Heine Optotechnik GmbH & Co. KG
Model
083
Catalog number
K-235.28.305
Device description
With Contact Plate
Published
2024-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053755201549Direct MarkingGS10
04053755201617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053755201549040537552015494053755201549
04053755201617040537552016174053755201617

GMDN Terms#

Term, Definition table
TermDefinition
Dermatoscope, opticalAn electrically-powered, hand-held instrument intended to be used for the direct microscopic examination of the external skin layers. The device has a built-in light source and magnification system that provides the user with the visualization of the structures of the epidermis and epidermal-dermal junction during dermatoscopy (also known as dermascopy). Oil may be applied to the skin to enhance skin transparency. This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).

Contacts#

Phone, Email table
PhoneEmail
+1 (603) 742-7103service@heine-na.com

Regulatory Flags#

DUNS number
315274563
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053755203567BETA X VET OPHTHALMOSCOPE000G-140.28.3302026-03-31
04053755203574BETA X VET OTOSCOPE000G-130.28.3302026-03-31
04053755207541XV4 BETA X VET SPECULUM4 MMG-000.21.3202026-03-31
04053755207558XV6 BETA X VET SPECULUM6 MMG-000.21.3212026-03-31
04053755207565X CHANGE SYSTEM SL-MAGNIFIER 000G-000.21.2202026-03-31
04053755180172HEINE SIGMA®250000C-008.33.3402016-09-24
04053755180738HEINE SIGMA®250000C-008.33.3412016-09-24
04053755202690DELTA 30 UV002026-03-02
04053755203314DELTA XLEDK-130.28.3302025-12-03
04053755203321DELTA X CPP00K-000.34.2372025-12-03
04053755203338DELTA X CPG00K-000.34.2382025-12-03
04053755202904BETA X Otoscope3xB-130.28.3302025-07-18
04053755202911BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755202744BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755203031BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755202973FINOFF TRANSILLUMINATOR2,5 VC-001.17.0802025-07-17
04053755202966BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755203048GAMMA 3.2000M-000.09.9472025-07-17
04053755202928DELTAoneBLACK WHITE EDITIONK-214.28.3052025-04-30
04053755136988GAMMA 3.1000M-000.09.9412022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
B366LED0204R00PORTALEDEclerisKYT2026-02-11
B366LED0204PORTALEDEclerisKYT2026-01-23
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
B366LED0203PORTALEDEclerisKYT2025-11-21
10860008900361ClearSpecClearspec LLCKYT2025-10-29
20860008900368ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
00714646001375Rechargeable Light SourceBionix, LLCKYT2025-02-25
07290016672756TytoProTYTO CARE LTDKYT2024-05-26
07290016672763TytoHomeTYTO CARE LTDKYT2024-05-26
04053755201655DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
00811331011654TruBrite Adhesive Retractor LightTz Medical, Inc.KYT2023-10-20
00816835024254IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024261IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024278IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024285IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024292IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00810132041792HCSConcordance Healthcare Solutions LLCKYT2023-07-28
00810114912010SurgiTelSurgitelKYT2023-01-12
00810114912027SurgiTelSurgitelKYT2023-01-12
00810114912034SurgiTelSurgitelKYT2023-01-12
00810114912041SurgiTelSurgitelKYT2023-01-12
00810114912058SurgiTelSurgitelKYT2023-01-12
00810114912065SurgiTelSurgitelKYT2023-01-12
00634782099480Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099497Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099503Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099510Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099527Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11