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OPYG-12-12 Peyman G. Capsulotomy Yag Laser Lens

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref 735

by Ocular Instruments Inc.

Identity

Trade Name
OPYG-12-12 Peyman G. Capsulotomy Yag Laser Lens EUDAMED
Peyman G. Capsulotomy Yag Laser Lens FDA UDI
Generic Name
Laser lens, ophthalmic, surgical FDA UDI
Device Name
Contact Ophthalmic EUDAMED
Model / Reference
735 EUDAMED
OPYG-12-12 FDA UDI

Identifiers

Primary DI / UDI-DI
00630238007351 EUDAMEDFDA UDI
Basic UDI-DI
06302381262637 EUDAMED
Direct Marketing DI
00630238020053 EUDAMED
510(k) Number
K875087 FDA UDI
FDA Product Code
HJK FDA UDI
EMDN Code
Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
GMDN Term
Laser lens, ophthalmic, surgical FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
886.1385 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

OPYG-12-12 Peyman G. Capsulotomy Yag Laser Lens by Ocular Instruments, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Ocular Instruments Inc.
EUDAMED SRN
US-MF-000007216
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED c56a2e6b-1ff4-4430-95d9-fff176f67232 61 fields · synced Sep 30, 2026
  • FDA UDI 19dd0e87-be6a-4dde-9a45-2fe408f63e8f 33 fields · synced May 30, 2026
  • FDA 510(k) K875087 1 fields · synced May 18, 2026