ZX2 Laser System
by Lzr7, Inc.
510(k) K150466
ZX2 Laser System is a medical device (FDA Class II; FDA product code ILY, Lamp, Infrared, Therapeutic Heating) made by Lzr7, Inc., cleared under FDA 510(k) K150466 on 8 Jun 2015, 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 | NumberK150466 | Date8 Jun 2015 | StatusActive |
Official records
- FDA 510(k) database K150466
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ILY
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code ILY (Lamp, Infrared, Therapeutic Heating).
- iLux LF R05 1LFR05 by MECTRONIC MEDICALE SRL
- NANOBEAM 940, MODEL 940-900-02 by Davaray, Inc.
- 104 LED Cluster Probe 660nm & 850nm 2W 2.3 by THOR PHOTOMEDICINE INC.
- CYNOSURE 1064NM DIODE LASER by Cynosure, LLC
- MEDX 1000 SERIES by Medx Electronics, Inc.
- THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE by Thor International
- SURGICAL PATIENT WARMER, MODEL PW820 JHU by FISHER & PAYKEL HEALTHCARE, INC.
- EM PROBE, EM PAD by Em Probe, Inc.
- LightStim Professional LED Bed by LED Intellectual Properties
- Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 by Usa Laser Biotech, Inc.