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SynergEyes casted button

FDA UDI

Class II (US FDA UDI)

by Synergeyes, Inc.

Identity

Trade Name
SynergEyes casted button FDA UDI
Generic Name
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Device Name
SynergEyes petrafocon A hem-larafilcon A casted button FDA UDI
Model / Reference
petrafocon A hem-larafilcon A FDA UDI
Description
SynergEyes petrafocon A hem-larafilcon A casted button FDA UDI

Identifiers

Primary DI / UDI-DI
A50009 FDA UDI
510(k) Number
K083921 FDA UDI
FDA Product Code
HQD FDA UDI
GMDN Term
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.5916 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Rigid-gas-permeable corrective contact lens, daily-wear

SynergEyes casted button by Synergeyes, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid-gas-permeable corrective contact lens, daily-wear.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synergeyes, Inc.

Sources (1)

  • FDA UDI 292717be-6b36-4546-a254-1b3f9ecc0214 34 fields · synced Jun 8, 2026