Identity
- Trade Name
- Ophthalmic Slit Lamp Microscope FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- It is an AC-powered slit lamp Biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment. FDA UDI
- Model / Reference
- LS-1A FDA UDI
- Description
- It is an AC-powered slit lamp Biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973211070374 FDA UDI
- 510(k) Number
- K182306 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic examination slit lamp
Ophthalmic Slit Lamp Microscope by Chongqing Sunkingdom Medical Instrument Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182306 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
- Chongqing Sunkingdom Medical Instrument Co., Ltd
Sources (1)
- FDA UDI 22c73511-921b-4e7c-9800-4e5dd351d05d 34 fields · synced Jun 8, 2026