Visualase Envision Software System
by Biotex, Inc.
510(k) K063505
Visualase Envision Software System is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Biotex, Inc., cleared under FDA 510(k) K063505 on 12 Dec 2006, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063505 | Date12 Dec 2006 | StatusActive |
Official records
- FDA 510(k) database K063505
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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