Spectralis

FDA UDI

Class II (US FDA UDI)

by Heidelberg Engineering

Identity

Trade Name: SPECTRALIS FDA UDI
Generic Name: Scanning-laser retinal imaging system FDA UDI
Model / Reference: SP-PWS-1000A FDA UDI

Identifiers

Primary DI / UDI-DI: 04059237000044 FDA UDI
510(k) Number: K101223 FDA UDI
FDA Product Code: MYC FDA UDI
OBO FDA UDI
GMDN Term: Scanning-laser retinal imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic spectral-domain optical coherence tomography system Scanning-laser retinal imaging system

Spectralis by Heidelberg Engineering — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K101223 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Heidelberg Engineering

Sources (1)

FDA UDI 67ce2c28-d38e-4bfd-bcb2-80b5a755a105 33 fields · synced May 30, 2026