PureLase
by Canadian Pioneer Medical Technology Corporation
PureLase is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Canadian Pioneer Medical Technology Corporation, cleared under FDA 510(k) K232133 on 16 Apr 2024 and listed in FDA GUDID since 30 Jun 2025 (UDI-DI 00198715225501), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00198715225501 | Date30 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232133 | Date16 Apr 2024 | StatusActive |
Official records
- AccessGUDID record 00198715225501
- FDA 510(k) database K232133
Across registries
- FDA 510(k) K232133 decided 16 Apr 2024 Active
- FDA GUDID UDI-DI 00198715225501 listed 30 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K232133
- Listed FDA GUDID 00198715225501
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- General/multiple surgical carbon dioxide laser system
- Model / reference
- PureLase
- Primary DI / UDI-DI
- 00198715225501
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- General/multiple surgical carbon dioxide laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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