(90 days)
Not Found
No
The device description explicitly states "The Flex-laser 600 series is not a computer controlled device."
Yes
Explanation: The device is intended for the "treatment of selected vascular and pigmented lesions of the skin," which clearly indicates a therapeutic purpose.
No
Explanation: The device is intended for treatment of lesions, not for diagnosis. Its function involves photocoagulation of tissue.
No
The device description clearly details a physical laser system with hardware components (laser, handpiece, footswitch, cooling system) and does not mention being software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Flexelase 600 Series Ion Laser is a therapeutic device that uses laser light to treat lesions on the skin. It directly interacts with the patient's tissue.
- Intended Use: The intended use clearly states treatment of "selected vascular and pigmented lesions of the skin." This is a therapeutic application, not a diagnostic one performed on a sample outside the body.
The device description and intended use consistently describe a laser system used for direct treatment of skin conditions, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Flaxelase 600 Series Ion Laser is intended for use in the treatment of selected yascular and pigmented lesions of the skin, Laser light of a selected wavelength is used to photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue.
Flex-Lase 600 Ion Laser is intended for use in the the a treatment of salected pigmented and vascularized lesions of the skin. Representative indications for use are:
Flex-Lase Model 640 Laser System For vascular lesions: (Yellow - 568 nm)
- Capillary Hemangioma (port wine hemangioma)
- Strawberry hemangioma
- Telangectasia
- Rosacea
For pigmented lesions: (Yellow/Green - 568 nm and 520-530 nm).
- Freckles
- Age Spots
- Cafe-au-lait
- Lentigo
Flex-Lase Model 620 Laser System For Wascular Sesions: (Blue/Green - 488 nm and 514.5 nm)
- Capillary Hemangioma (port wine hemangioma)
- Strawberry Hemangioma
- Telangectasia
- Rosagea .
For pigmented lesions: (Green - p14.5 mm)
- Freckles
- Age Spots
- Cafe-Au-Lait
- Lentigo
Product codes (comma separated list FDA assigned to the subject device)
79GEX
Device Description
The Flex-Lase 600 Series Ion Laser submission covers all of the internal parts, subassemblies and components as well as The Flex-Lase Model 640 is a coninuous the completed device. wave krypton laser system emitting light at the 568 nm (yellow) and 520/530 nm (green) wavelengths. The Flex-Lase Model 620 is a continuous wave argon laser system emitting light at the 488 nm (blue) and the 514 nm (green) wavelengths.
Treatment beam output for the Flex-Lase Model 640 (krypton) is 1.0 Watt (yellow) and 3.0 Watts (yellow-green simultaneous). The power output for the Flex-Lase Model 620 (argon) is 5.5 watts blue-green or 2.0 watts green. The aiming beam is provided by an adjustable intensity incoherent white light source. Exposure times for the Flex-Lase 600 Series Ion Laser (in seconds) are 0.02, 0.05, 0.1. 0.25, 0.5, 1.0, and continuous.
Laser activation occurs by footswitch. Overall weight of the system is 112 lbs. (51 kg). The Flex-Lase 600 Series Ion Laser has a footprint of 16 X 24 inches (38 X 60 cm) and is 36 inches (90 cm) high.
The electrical power requirement is 208 VAC 40 amb single phase. Cooling is provided by external filtered flow-through tap water at a minimum rate of 2.5 gallons (9,5 liters) per minute.
Accessories available for use with the Flex-lase 600 Ton Laser include a fooysing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Flex-laser 600 series is not a computer controlled device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
NOV 26 1996
K9633/9
Flex-Lase 600 Series Ion Laser American Laser Medical November 7, 1996
Summary of Safety and Effectiveness Information
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name/Contact;
| Company: American Laser Medical |
|---|
| 1832 South 3850 West |
| Salt Lake City, UT 84104 |
| (801) 972-1311, FAX (801) 972-5251 |
- Contact: Mr. Daniel Hoefer Regulatory Affairs American Laser Medical 1832 South 3850 West Salt Lake City, UT 84104 (801) 972-1311, FAX (801) 972-5251
Name of Device:
Flex-Lase 600 Series Ion Laser Trade Name:
Common Name: Dermatology Laser
Classification:
Powered surgical laser instruments are assigned the unique device classification code 79GEX. The published physical description of this device is found in 21 CFR, & 878.4810 (a) specifically device classification section (2) . This describes argon laser systems. The American Laser Medical device may be configured as either an argon laser system or as system, however American Medical Laser krypton laser a maintains that there is no substantial difference between argon and krypton lasers for the purpose of classification. medical these lasers are considered Class II Presently, devices.
T
1
Flex-Lase 600 Series Ion Laser American Laser Medical November 7, 1996
Description of Device:
The Flex-Lase 600 Series Ion Laser submission covers all of the internal parts, subassemblies and components as well as The Flex-Lase Model 640 is a coninuous the completed device. wave krypton laser system emitting light at the 568 nm The Flex-Lase (yellow) and 520/530 nm (green) wavelengths. Model 620 is a continuous wave argon laser system emitting light at the 488 nm (blue) and the 514 nm (green) wavelengths.
Treatment beam output for the Flex-Lase Model 640 (krypton) is 1.0 Watt (yellow) and 3.0 Watts (yellow-green simultaneous). The power output for the Flex-Lase Model 620 (argon) is 5.5 The aiming beam is watts blue-green or 2.0 watts green. provided by an adjustable intensity incoherent white light Exposure times for the Flex-Lase 600 Series Ion Laser source. 0.02, 0.05, 0.1. 0.25, 0.5, 1.0, and (in seconds) are continuous.
Laser activation occurs by footswitch. Overall weight of the system is 112 lbs. (51 kg). The Flex-Lase 600 Series Ion Laser has a footprint of 16 X 24 inches (38 X 60 cm) and is 36 inches (90 cm) high.
The electrical power requirement is 208 VAC 40 amb single phase. Cooling is provided by external filtered flow-through tap water at a minimum rate of 2.5 gallons (9,5 liters) per minute.
Accessories available for use with the Flex-lase 600 Ton Laser include a fooysing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Flex-laser 600 series is not a computer controlled device.
Intended Use:
The Flaxelase 600 Series Ion Laser is intended for use in the treatment of selected yascular and pigmented lesions of the Laser light of a selected wavelength is used to skin, photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue.
Indications for Use:
Flex-Lase 600 Ion Laser is intended for use in the the a treatment of salected pigmented and vascularized lesions of the skin. Representative indications for use are:
2
Flex-Lase 600 Series Ion Laser American Laser Medica I
November 7, 1996
Flex-Lase Model 640 Laser System For vascular lesions: (Yellow - 568 nm)
- Capillary Hemangioma (port wine hemangioma) 1.
- Strawberry hemangioma 2.
-
- Telangectasia
- 4 . Rosacea
For pigmented lesions: (Yellow/Green - 568 nm and 520-530 nm).
-
- Freckles
- Age Spots 2.
- Cafe-au-lait 3.
- 4 . Lentigo
Flex-Lase Model 620 Laser System For Wascular Sesions: (Blue/Green - 488 nm and 514.5 nm)
- Capillary Hemangioma (port wine hemangioma)
-
- Strawberry Hemangioma
- Telangectasia 6
- Rosagea .
For pigmented lesions: (Green - p14.5 mm)
- Freckles
-
- Age Spots
- Cafe-Au-Lait
- Lentigo
Comparison of Device Characteristics:
For vascular lesions:
The Flex-Lase 600 Ion Leser System is substantially equivalent to the NGM Spectrum KI, the Metalaser Vasculase and the Coherent artisan already in gommercial distribution. una materials, Intended use, method of manufacture, design, procautions cautions . and treatment parameters warninga. are substantially the same.
For pigmented lesions:
The Flex-Lase 600 Series Ion Leser Bystem is supersurielly equivalent to the HGM Spectrum KI, the Matalaser Vasculass and the Coherent Artisan already in commercial distribution. ਿਸ਼ਰੂ ਫ
3
Flex-Lase 600 Series Ion Laser American Laser Medical, Inc.
November 7, 1996
materials, design, intended use, method of manufacture, warnings, cautions and precautions are substantially the same.
Feature comparison tables which follow illustrate the equivalence of features of the Flex-Lase 600 and equivalent available systems. See also appendix II for marketing materials on substantially equivalent devices.
4
ين جاء
. • •
Laser Equivalency Table Vascular Lesions
| | FLEX-LASE
MODEL 620 | FLEX-LASE
MODEL 640 | HGH K1 | METALASER
VASCULASE | COHERENT
ARTISAN |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------|
| Type | Con-
tinuous.
wave
argon | Continuous
wave
krypton | Continuous
Wave
krypton | Copper
Vapor
Laser | Continuous
wave
Argon/Dye |
| Wavelength
(nano-
meters) | 514, or
488/514 | 568, or
568/520-
530 | 568,
520/530 | 511, 578 | 514 only,
or
488/514,
or 577-630
selectable |
| Exposure
Time (sec.) | 0.02,
0.05,
0.1,
0.25,
0.5, 1.0,
and cont. | Same | 0.05, 0.1,
0.2, 0.5,
1.0, 2.0,
5.0, and
continuous | 0.075,
0.1, 0.2,
0.3, and
continuous | 0.01,
0.02,
0.05, 0.1,
0.2, 0.5,
1.0, 2.0,
5.0, cont. |
| Output Mode | Multimode | Multimode | Multimode | Multimode | Multimode |
| Beam
Delivery | Handpiece
via fiber
optic | Handpiece
via fiber
optic | Handpiece
via fiber
optic | Handpiece
via fiber
optic | Handpiece
via fiber
optic |
| Stability
of Output
Energy | +/- 10% | +/- 10% | +/- 10% | +/- 20% | +/- 5% |
| Spot Size
(mm) | 0.25,
0.5, 1.0 | 0.25, 0.5,
1.0 | 0.1, 0.2,
1.0 | 0.1, 0.2,
1.0 | 0.1, 0.25,
0.5, 1.0,
fixed,
variable
0.2-2.5 |
| Energy
density | 2-30
J/cm² | 2-30 J/cm² | 2-30 J/cm² | 4-15 J/cm² | 2-30 J/cm² |
| Aiming
beam | Adjust-
able in-
coherent
white
light
source | Adjustable
incoherent
white
light
source | HeNe
(633nm)
adjustable
to 5 mW | HeNe (633
nm) | HeNe (633
nm) |
| | FLEX-LASE
MODEL 620 | FLEX-LASE
MODEL 640 | HOM KI | METALASER
VASCULASE | COHERENT
ARTISAN |
| Cooling | Filtered
flow-
through
tap water
2.5
gal/min | Filtered
flow-
through
tap water
2.5
gal/min | Internal
liquid
cooled | Air-
cooled,
40F-80F
ambient
air temp. | Filtered
flow-
through
tap water
2.5
gal/min |
| Electrical
Require-
ments | 208-240
VAC 40
amp
single
phase
50/60 Hz | 208-240
VAC 40 amp
single
phase
50/60 Hz | 208-240
VAC 40 amp
50/60 Hz
single
phase | 208 VAC
+/- 10%,
20 amp
60Hz
single
phase | 208 VAC 50
amp 50/60
Hz 3 phase |
| Indications
for
Vascular
lesions | Capillary
(port
wine)
heman-
gioma,
Straw-
berry
heman-
gioma,
Telangec-
tasia,
Rosacea | Capillary
or port
wine
hemangioma
Strawberry
hemangioma
Telangec-
tasia
Rosacea | Vascular
Lesions
( same ) | Vascular
Lesions
( same ) | Vascular
Lesions
( same ) |
| K Number | | | K913428,
K913569 | K903883 | na |
| | FLEX-LASE
MODEL 620 | FLEX-LASE
MODEL 640 | HGM K1 | METALASER
VASCULASE | COHERENT
ARTISAN |
| Type | Continuous
wave
argon | Continuous
wave
krypton | Continuous
Wave
krypton | Copper
Vapor
Laser | Continuous
wave
Argon/Dye |
| Wavelength
(nano-
meters) | 514, or
488/514 | 568, or
568/520-
530 | 568,
520/530 | 511, 578 | 514 only, or
488/514, or 577-630
selectable |
| Exposure
Time (sec.) | 0.02,
0.05,
0.1,
0.25,
0.5, 1.0,
and cont. | Same | 0.05, 0.1,
0.2, 0.5,
1.0, 2.0,
5.0, and
continuous | 0.075,
0.1, 0.2,
0.3, and
continuous | 0.01,
0.02,
0.05, 0.1,
0.2, 0.5,
1.0, 2.0,
5.0, cont. |
| Output Mode | Multimode | Multimode | Multimode | Multimode | Multimode |
| Beam
Delivery | Handpiece
via fiber
optic | Handpiece
via fiber
optic | Handpiece
via fiber
optic | Handpiece
via fiber
optic | Handpiece
via fiber
optic |
| Stability
of Output
Energy | +/- 10% | +/-10% | +/-10% | +/-20% | +/- 5% |
| Spot Size
(milli-
meters) | 0.25,
0.5, 1.0 | 0.25, 0.5,
1.0 | 0.1, 0.2,
1.0 mm | 0.1, 0.2,
1.0 mm | 0.1, 0.25,
0.5, 1.0,
fixed,
variable
0.2-2.5 mm |
| Energy
density | 2-30 J/cm2 | 2-30 J/cm2 | 2-30 J/cm2 | 4-15 J/cm2 | 2-30 J/cm2 |
| Aiming
beam | Adjust-
able in-
coherent
white
light
source | Adjustable
incoherent
white
light
source | HeNe
(633nm)
adjustable
to 5 mW | HeNe (633 nm) | HeNe (633 nm) |
| | FLEXI-LASE
MODEL 620 | FLEX-LASE
MODEL 640 | EGM K1 | METALASER
VASCULASE | COHERENT
ARTISAN |
| Cooling | Filtered
flow-
through
tap water
2.5
gal/min | Filtered
flow-
through
tap water
2.5
gal/min | Internal
liquid
cooled | Air-
cooled,
40F-80F
ambient
air temp. | Filtered
flow-
through
tap water
2.5
gal/min |
| Electrical
Require-
ments | 208-240
VAC 40
amp
single
phase
50/60 Hz | 208-240
VAC 40 amp
single
phase
50/60 Hz | 208-240
VAC 40 amp
50/60 Hz
single
phase | 208 VAC
+/- 10%,
20 amp
60Hz
single
phase | 208 VAC 50
amp 50/60
Hz 3 phase |
| Indications
for
Pigmented
lesions | Freckles,
Age
spots,
cafe-au-
lait,
lentigo | Freckles,
Age spots,
cafe-au-
lait
lentigo | Pigmented
Lesions
(same) | Pigmented
Lesions
(same) | Pigmented
Lesions
(same) |
| K Number | | | K913428,
K913569 | K903883 | na |
5
i
6
.
.
..
・・
...
. . ...
Laser Equivalency Table
Pigmented Lesions
:
7
F
: 翻 :
: ----:
:
.... ....
: : : : : : : : : : :
..............................................................................................................................................................................
·
"" "
:
റ്റ