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Powered Laser Surgical Instrument－APOLLO V+ Medical Platform
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Powered Laser Surgical Instrument－APOLLO V+ Medical Platform FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Model / Reference
- MLP-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970285176018 FDA UDI
- 510(k) Number
- K113018 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Yes
FDA UDI
Category: General/multiple surgical frequency-doubled solid-state laser system
Powered Laser Surgical Instrument－APOLLO V+ Medical Platform by Beijing Syntech Laser Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
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
- Beijing Syntech Laser Co., Ltd.
Sources (1)
- FDA UDI c2858ba0-8c00-452f-9895-3a486ed01ffa 33 fields · synced May 30, 2026