510(k) DEN230007
- Device
- LightStrike+ (MXSUV1-SL and MXSUV1-FT)
- Applicant
- Xenex Disinfection Services, Inc.
- 510(k) number
- DEN230007
- Product code
- QXJ
- Decision
- Unknown (DENG)
- Decision date
- 2023-09-01
- Date received
- 2023-02-01
- Regulation
- 880.6510
- Classification name
- Whole Room Microbial Reduction Device
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Juan L. Gonzalez
- Address
- 1074 Arion Cir., Suite 116 San Antonio TX US 78254 78254
FDA Registration Numbers#
- 3013869012
- 3014531752
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QXJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242604 | Helios+ UV-C System | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | 2025-05-27 |