← Back to catalogue
Powered Laser Surgical Instrument APOLLO IV+ Medical Platform
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Powered Laser Surgical Instrument APOLLO IV+ Medical Platform FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Model / Reference
- MLP-10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970285176148 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
- Not 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
Powered Laser Surgical Instrument APOLLO IV+ Medical Platform by Beijing Syntech Laser Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
Cleared under the same submission
K113018 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
- Beijing Syntech Laser Co., Ltd.
Sources (1)
- FDA UDI 16a24ac8-c1e4-46b9-aeba-cc7f456e4c8e 34 fields · synced May 30, 2026