FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SPECTRALIS
DI: 04059237000488
·
Model: Software with HEYEX 2 V6.14_US
·
Heidelberg Engineering GmbH
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SPECTRALIS
- Primary DI
- 04059237000488
- Version / Model
- Software with HEYEX 2 V6.14_US
- Company Name
- Heidelberg Engineering GmbH
- Labeler DUNS
- 329833875
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-21
- Public Version
- 6
- Public Version Date
- 2026-04-13
- Public Version Status
- Update
- Public Device Record Key
- 0d724cbc-04ba-4160-924b-0b6415c73139
- Distribution End Date
- 2025-12-08
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MYC | Ophthalmoscope, Laser, Scanning | Ophthalmic | 886.1570 | 2 |
| OBO | Tomography, Optical Coherence | Ophthalmic | 886.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47952 | Scanning-laser retinal imaging system | An assembly of electrically-powered ophthalmic instruments and digital image capturing/processing devices intended to use a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of choroiditis. | No | Active |
| 58850 | Ophthalmic spectral-domain optical coherence tomography system | A mobile assembly of devices designed to use near infrared (NIR) LED light aimed into the eye to acquire, process, display and save in vivo depth-resolved images of anterior and posterior ocular tissue microstructures in clinical and perioperative examination through the use of interchangeable lenses. Spectral domain optical coherence tomography (SDOCT) is intended to aid in the diagnosis and evaluation of physiologic and pathologic conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04059237000488 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192391 | 000 |