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The Alma Lasers Soprano Titanium Laser System consists of:
•System console (contains the laser diodes, the system software, power supply, andvarious other electronic and mechanical parts)
•Operator control panel with touch-screen technology (GUI)
•Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously
Premarket Notification Traditional 510(k) Section 8: Page 2 of 4
Alma Lasers Soprano Titanium
• 810 nm applicator
• 755 nm applicator
• Small NIR applicator
• Footswitch and other laser safety accessories
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121829 ()
AASP05091845BSR0001
- Dermatological diode laser system
- Intense pulsed light skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121812 ()
AASP30111208
- Dermatological diode laser system
- Intense pulsed light skin surface treatment system
The A-Series Spindle Single Flat Panel Monitor is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution
- 00724995190309 ()
LAS000007
- Medical monitor/light mount
The Single Flat Panel Monitor Yoke Assembly is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution
- 00724995171759 ()
10100167
- Medical monitor/light mount
10 Panel Drug Test Cup – AMP, BZO, BUP, COC, MET, MTD, MDMA, OPI, OXY, THC
DEUS VULT, LLC
P33-10-MET
Not in Commercial Distribution
- 00860004081661 ()
- 00860004081654 ()
- 00860004081647 ()
P33-10-MET
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution
- 00860003196991 ()
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution
- 00860003196953 ()
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel Clear Scan Drug Test Cup Drug Combo: BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
CSC-564
In Commercial Distribution
- 00850557007881 ()
- 00850557007898 ()
- 10850557007895 ()
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
PSC-DOA-564
In Commercial Distribution
- 00850557007522 ()
- 00850557007539 ()
- 10850557007536 ()
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PSC-DOA-264
In Commercial Distribution
- 00850557007461 ()
- 00850557007478 ()
- 10850557007475 ()
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical