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The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that opehttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageDataLoaded=false&pageMode=create#rates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures.
The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery
FOTONA d.o.o.
M021-5AF/2 STAND
Not in Commercial Distribution
- 03830054230491 ()
- General/multiple surgical solid-state laser system
- Multi-modality skin surface treatment system generator
- Dermatological solid-state laser system
- Dental solid-state laser system
The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures.
The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
FOTONA d.o.o.
M002-6A/2
Not in Commercial Distribution
- 03830054230293 ()
- General/multiple surgical solid-state laser system
- Multi-modality skin surface treatment system generator
- Dermatological solid-state laser system
- Dental solid-state laser system
The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range.
The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and
dermatological procedures.
The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
FOTONA d.o.o.
M021-5AF/1
Not in Commercial Distribution
- 03830054230194 ()
- General/multiple surgical solid-state laser system
- Multi-modality skin surface treatment system generator
- Dermatological solid-state laser system
- Dental solid-state laser system
"The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures.
The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. "
FOTONA d.o.o.
M021-5AF/2
Not in Commercial Distribution
- 03830054230095 ()
- General/multiple surgical solid-state laser system
- Multi-modality skin surface treatment system generator
- Dermatological solid-state laser system
- Dental solid-state laser system
Compact device for the dry thermal examination of the vestibular organ.
Characteristics:
Electronically controlled air calorisator with two temperature levels to be selected, preparation mode, stimulation mode (cold or warm stimulation depending on the preselected temperature), heating off and no airflow (saving mode, standby).
ATMOS MedizinTechnik GmbH & Co. KG
Varioair
In Commercial Distribution
- 04250365143065 ()
- Diagnostic caloric vestibular stimulation system
Multi-modality (electrical stimulation/ultrasound/low level laser) physical therapy system
Enraf-Nonius B.V.
1498941
In Commercial Distribution
- 08720618311139 ()
- Multi-modality physical therapy system, professional-use
Philips EE Starter Kit, Base Kit and PerforMax, Single Use
Respironics, Inc.
Entrainment Elbow Starter Kit, Base + PerforMax SU
In Commercial Distribution
- 00606959042520 ()
1074043
- CPAP/BPAP face mask, reusable
- Ventilator breathing circuit, single-use
- CPAP/BPAP face mask, single-use
Dorma 200, with Humidifier, Pico, China
Respironics, Inc.
00
In Commercial Distribution
- 00606959040427 ()
CNV207HN1
- Heated respiratory humidifier
- CPAP/BPAP nasal mask, reusable
- Home CPAP unit
Dorma 500 Auto, with Humidifier, Pico, China
Respironics, Inc.
00
In Commercial Distribution
- 00606959040410 ()
CNV507HN1
- Heated respiratory humidifier
- CPAP/BPAP nasal mask, reusable
- Home CPAP unit
Sterrad NX Validation Kit
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
20254
Not in Commercial Distribution
- 10705037016594 ()
20254
- Biological sterilization indicator
- Instrument tray, reusable
- Sterilization packaging, single-use
- Aerobic laboratory incubator
- Chemical/physical sterilization process indicator