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Phakos

FDA UDI

Class II (US FDA UDI)

by Phakos

Identity

Trade Name
PHAKOS FDA UDI
Generic Name
General cryosurgical system, cryogen gas, mechanical FDA UDI
Device Name
Disposable Retinal Cryo Probe FDA UDI
Model / Reference
MV CY 100 FDA UDI
Description
Disposable Retinal Cryo Probe FDA UDI

Identifiers

Catalog Number
MV CY 100 FDA UDI
Primary DI / UDI-DI
B564MVCY1000 FDA UDI
510(k) Number
K162756 FDA UDI
FDA Product Code
HRN FDA UDI
GMDN Term
General cryosurgical system, cryogen gas, mechanical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4170 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: General cryosurgical system, cryogen gas, mechanical

Phakos by Phakos — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General cryosurgical system, cryogen gas, mechanical.

Cleared under the same submission

K162756 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phakos

Sources (1)

  • FDA UDI 0244ed76-ee25-4481-8cd4-016ea6d263fc 35 fields · synced Jun 8, 2026