Product areas
FDA product code distribution
Alma Lasers, Inc.
Country / region:United States (US)
510(k) submissions
12
Filtered: GEX
Latest clearance
2025-09-24
Product codes
1
GEX
510(k) submissions
12 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories | GEX | Class 2 | 2025-09-24 |
| K251230 | The Alma Hybrid Laser System | GEX | Class 2 | 2025-05-21 |
| K243044 | Alma Harmony | GEX | Class 2 | 2025-04-11 |
| K233024 | Alma Harmony | GEX | Class 2 | 2024-02-08 |
| K230308 | Alma Harmony | GEX | Class 2 | 2023-03-01 |
| K230371 | The Alma Soprano Titanium | GEX | Class 2 | 2023-02-22 |
| K222064 | The Alma Soprano Titanium | GEX | Class 2 | 2022-10-12 |
| K212073 | Alma Diode Tabletop Laser | GEX | Class 2 | 2022-07-14 |
| K203441 | The Alma Hybrid Laser System | GEX | Class 2 | 2021-07-02 |
| K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules | GEX | Class 2 | 2018-01-09 |
| K170850 | Alma Q | GEX | Class 2 | 2017-06-15 |
| K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece | GEX | Class 2 | 2017-05-31 |
Company profile
- Canonical name
- Alma Lasers, Inc.
- Aliases
- Alma Lasers , Ltd.
- Country
- United States(US)
Cited predicates
32- K103501
—
—
Not ingested - K203441
The Alma Hybrid Laser System
- K230441
—
—
Not ingested - K103501
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
—
- K072564
—
—
Not ingested - K170850
Alma Q
- K203441
The Alma Hybrid Laser System
- K210371
—
—
Not ingested - K230308
Alma Harmony
- K230371
The Alma Soprano Titanium
- K231054
V-Laser
- K222064
The Alma Soprano Titanium
- K222064
The Alma Soprano Titanium
- K181298
—
—
Not ingested - K072564
—
—
Not ingested - K053604
—
—
Not ingested - K033946
—
—
Not ingested - K141237
—
—
Not ingested - K172193
Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
- K160952
Alma Diode Tabletop Laser
- K080463
—
—
Not ingested - K103501
—
—
Not ingested - K170060
M22 and ResurFx Systems
- K050779
—
—
Not ingested - K170626
Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece
- K140009
—
—
Not ingested - K032667
—
—
Not ingested - K040384
—
—
Not ingested - K992597
—
—
Not ingested - K132185
FAMILY OF COOLGLIDE AESTHETIC LASERS
—
- K140009
SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM
—
- K153671
Family of CoolGlide Aesthetic Lasers
Alma Lasers, Inc. references 32 predicate/reference devices
Cited as predicate
27- K252599
Diode Laser Therapy Systems (WLA-02)
- K252599
Diode Laser Therapy Systems (WLA-02)
- K252561
BTL-754FF
- K251230
The Alma Hybrid Laser System
- K250206
Diode laser system (Night Universe; Predator)
- K242859
VEGA
- K241951
Lasya-Trinity
- K241092
Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
- K240474
Multi-function Platform Systems (BL-M10)
- K233024
Alma Harmony
- K233024
Alma Harmony
- K233024
Alma Harmony
- K233024
Alma Harmony
- K231896
Diode Laser Therapy System
- K230580
Diode Laser System
- K230371
The Alma Soprano Titanium
- K230308
Alma Harmony
- K222915
Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS
Canadian Pioneer Medical Technology Corporation (Cpmt Laser)
- K222862
SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC
- K222221
DEKA HELIX
- K222064
The Alma Soprano Titanium
- K211979
Lumenis Y&R Laser System
- K211722
Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
- K201594
Primelase Excellence
- K200118
Diode Laser Therapy Device
- K191162
EpiLaze Multi-wavelength Laser
- K172193
Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
27 submissions cite Alma Lasers, Inc. as a predicate