SPECTRALIS

Basic Information

• Brand Name: SPECTRALIS
• Primary DI: 04059237000884
• Version / Model: S1002
• Company Name: Heidelberg Engineering GmbH
• Labeler DUNS: 329833875
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-26
• Public Version: 1
• Public Version Date: 2022-11-03
• Public Version Status: New
• Public Device Record Key: aa344035-0132-4640-9e90-3a0f38267aa2

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: Yes
• 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 ophthalmic imaging system	An assembly of electrically-powered ophthalmic instruments and digital image capturing/processing devices that uses 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, e.g., assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of chorioditis.	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	04059237000884	GS1

Premarket Submissions

Submission Number	Supplement Number
K201252	000