Identity
- Trade Name
- MARCO FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capusule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment. FDA UDI
- Model / Reference
- MARCO ULTRA M4 FDA UDI
- Description
- An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capusule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560323648465 FDA UDI
- 510(k) Number
- K162636 FDA UDI
- FDA Product Code
- HJO FDA UDI
- GMDN Term
- Ophthalmic examination slit lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic examination slit lamp
Marco by Takagi Seiko Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic examination slit lamp.
- Mediworks — SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. · Class II
- ILLUMINIX — Illuminix Industries LLC · Class II
- Visionix — RIGHT MFG. CO., LTD. · Class II
- Slit Lamp BQ 900 — Haag-Streit AG · Class II
- S4 OPTIK — COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL · Class II
- SLH 5XC 6V TBL USA — KEELER LIMITED · Class II
- SLH 5XC 6V TBL — KEELER LIMITED · Class II
- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
Cleared under the same submission
K162636 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Takagi Seiko Co., Ltd.
Sources (1)
- FDA UDI af4386d5-ee3b-4cd0-aa0e-e3f5c2be1b66 35 fields · synced May 31, 2026