(85 days)
Not Found
No
The summary describes a laser system with different wavelengths and operating modes for various aesthetic and surgical applications. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as therapeutic in the performance studies section, which references IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. Additionally, its intended uses, such as coagulation and hemostasis of vascular lesions, treatment of wrinkles, and hair removal, clearly fall under the definition of therapy.
No
The device is intended for aesthetic and surgical applications involving ablation, excision, incision, and photothermolysis of soft tissue, as well as for treating vascular and pigmented lesions, wrinkles, and unwanted hair. These are therapeutic and aesthetic uses, not diagnostic ones.
No
The device description clearly states it is a flash lamp pumped Nd:Yag laser system with an articulated arm and different size tips, indicating it is a hardware device that emits laser radiation. While it mentions software verification and validation, this is in the context of controlling the hardware.
Based on the provided information, the Alma Q laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Alma Q Laser's Intended Use: The Alma Q laser is intended for aesthetic and surgical applications that involve direct interaction with the patient's soft tissue. It is used for procedures like ablation, excision, incision, photothermolysis, tattoo removal, hair removal, and treatment of various skin conditions. These are all procedures performed on the patient's body, not on specimens taken from the body.
- Device Description: The device description details a laser system that emits radiation and is used with handpieces that contact the patient's skin. This aligns with a therapeutic or surgical device, not an IVD.
- Lack of IVD-related terms: The document does not mention any analysis of biological specimens, laboratory testing, or diagnostic purposes in the context of analyzing samples.
Therefore, the Alma Q laser is a therapeutic/surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Alma Q laser is intended for use in aesthetic and surgical applications requiring the ablation, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery.
a) LP1064nm
- For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
- The Alma Q laser system is also indicated for the treatment of wrinkles.
- The Alma Q is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
- The Alma Q laser system is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin.
- The intended use of the integral cooling system in the Alma Q laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
b) QS 532nm - Tattoo removal
-Red inks
-Blue and light blue inks
-Green inks - Treatment of benign vascular lesions
-Telangiectasias
-Spider angiomas
-Cherry angiomas
-Spider nevi - Treatment of benign pigmented lesions
-Cafe-au-lait birthmarks solar lentigines
-Solar lentigines
-Becker's nevi
-Freckles
-Nevus spilus
-Nevus of ota - Incision, excision, ablation, and vaporization of soft tissue in general dermatology
c) QS 1064nm
The Alma Q laser treatment system is intended for use:
For the removal or lightening of unwanted facial or body hair.
For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery,
Benign dermal pigmented lesions (dermal melanocytosis); and
For tattoo removal (dark and blue inks).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The subject device, Alma Q Laser incorporates a flash lamp pumped Nd:Yag laser. The radiation emitted by this device has the ideal 1064nm wavelength. It also incorporates a built-in frequency conversion technology to obtain the 532nm (green) wavelength. The laser system is operated with an articulated arm system for transmitting the laser radiation with different size tips. Alma Q can operate in Q-switching mode and produce 1064nm wavelength beam. This beam can also be efficiently converted into 532nm wavelength beam using a KTP crystal. This laser can also operate in long-pulsed mode at 1064nm wavelength. The system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas.
The material that could contact the patient during device use is aluminum with limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, facial or body hair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
user facilities such as hospitals, physicians' offices and medical spas.
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)
IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety
IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance
IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard: Usability
IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1 Safety of laser products-Part 1: Equipment Classification, requirements and user's guide
IEC 62304 Medical device software - Software life cycle processes
In addition software verification and validation testing was performed and biocompatibility was established.
In all instances, the Alma Q Laser functioned as intended and the results observed were as expected.
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a triple-line design representing the bodies.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2017
Alma Lasers LTD Rekha Anand Regulatory Associate Halamish St Pob 3021 Industrial Park Caesarea, 3088900 Il
Re: K170850
Trade/Device Name: Alma O Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: March 21, 2017 Received: March 22, 2017
Dear Rekha Anand:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Alma O Laser
Indications for Use (Describe)
The Alma Q laser is intended for use in aesthetic and surgical applications requiring the ablation, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery.
a) LP1064nm
-
- For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
-
- The Alma Q laser system is also indicated for the treatment of wrinkles.
- The Alma Q is also indicated for the removal of unwanted hair and for the treatment of 3. pseudofolliculitis barbae (PFB).
-
- The Alma Q laser system is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin.
-
- The intended use of the integral cooling system in the Alma O laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
- b) OS 532nm
-
- Tattoo removal
- -Red inks
- -Blue and light blue inks
- -Green inks
-
- Treatment of benign vascular lesions
- -Telangiectasias
- -Spider angiomas
- -Cherry angiomas
- -Spider nevi
-
- Treatment of benign pigmented lesions
- -Cafe-au-lait birthmarks solar lentigines
- -Solar lentigines
- -Becker's nevi
- -Freckles
- -Nevus spilus
- -Nevus of ota
-
- Incision, excision, ablation, and vaporization of soft tissue in general dermatology
-
3
c) QS 1064nm
The Alma Q laser treatment system is intended for use:
For the removal or lightening of unwanted facial or body hair.
For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery,
Benign dermal pigmented lesions (dermal melanocytosis); and
For tattoo removal (dark and blue inks).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Section 8 510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Owner Name | Alma Lasers Inc. |
|---|---|
| Address | 485 Half Day Rd. Suite 100 |
| Buffalo Grove, IL 60089 | |
| Contact Person | Kathy Maynor |
| Regulatory Consultant | |
| Email : kathy.maynor@almalasers.com | |
| Phone: 352-586-3113 | |
| Summary Preparation Date | March 21, 2017 |
I. Submitter Information [21 CFR 807.92(a) (1)]
II. Name of device [21 CFR 807.92 (a) (2)]
| Trade or Proprietary Name | Alma Q Laser | ||
|---|---|---|---|
| Common Device Name(s) and | |||
| Regulatory Class | Product | ||
| Code(s) | Classification Panel | Regulation | |
| Laser Powered Surgical | |||
| Instruments (& Accessories) | |||
| Class II | GEX | General & Plastic | |
| Surgery Panel, 79 (SU) | § 878.4810, Laser surgical | ||
| instrument for use in general and | |||
| plastic surgery and dermatology | |||
| Surgical Powered Lasers and Delivery Devices/Hand piece | |||
| Accessories |
III. Predicate Devices [21 CFR 807.92(a) (3)]
| 510(k) # | Trade Name | Product Code |
|---|---|---|
| K040384 | Mydon/Quantel Derma | GEX |
| K032667 | Naturalase/Focus Medical | GEX |
| K992597 | Naturalase/Focus Medical | GEX |
IV. Device Description [21 CFR 807.92(a) (4)]
The subject device, Alma Q Laser incorporates a flash lamp pumped Nd:Yag laser. The radiation emitted by this device has the ideal 1064nm wavelength. It also incorporates a built-in frequency conversion technology to obtain the 532nm (green) wavelength. The laser system is operated with an articulated arm system for transmitting the laser radiation with different size tips. Alma Q can operate in Q-switching mode and produce 1064nm wavelength beam. This
5
beam can also be efficiently converted into 532nm wavelength beam using a KTP crystal. This laser can also operate in long-pulsed mode at 1064nm wavelength. The system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas.
The material that could contact the patient during device use is aluminum with limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
V. Intended use of device and Indications for Use [21 CFR 807.92(a) (5)]
The Alma O laser is intended for use in aesthetic and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery.
The indications for use for the Alma Q laser share the same or similar indications for use as the predicate devices in that:
LP1064mm
- For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, 1. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
- The Alma Q laser system is also indicated for the treatment of wrinkles. 2.
- The Alma Q is also indicated for the removal of unwanted hair and for the treatment of 3. pseudofolliculitis barbae (PFB).
-
- The Alma Q laser system is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin.
- న. The intended use of the integral cooling system in the Alma Q laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
QS 532nm
- Tattoo removal -Red inks -Blue and light blue inks -Green inks
-
- Treatment of benign vascular lesions
- -Telangiectasias -Spider angiomas -Cherry angiomas
- -Spider nevi
-
- Treatment of benign pigmented lesions -Cafe-au-lait birthmarks -Solar lentigines -Becker's nevi -Freckles
6
-Nevus spilus -Nevus of ota
-
- Incision, excision, ablation, and vaporization of soft tissue in general dermatology
QS 1064nm
The Alma Q laser treatment system is intended for use:
For the removal or lightening of unwanted facial or body hair.
For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery,
Benign dermal pigmented lesions (dermal melanocytosis); and
For tattoo removal (dark and blue inks).
VI. Summary of technological characteristics of the device compared to the predicate[21 CFR 807.92(a)(6)]
The technological principles underlying the subject and the predicate devices are the same. A table comparing the key features of the subject and predicate devices is provided on the following page.
7
| Characteristic | Alma Q | Mydon
(K040384) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wavelength | 1064nm | 1064nm |
| Output energy | 40J | 40J |
| Fluence | 10-450J/cm2
3.0mm spot = 30-300J/cm2
5mm spot = up to 240 J/cm2
7mm spot = 15-100 J/cm2
8mm collimated = up to 58J/cm2 | 10-450J/cm2
1.5mm spot = 160-450 J/cm2
3.0mm spot = 30-300J/cm2
5mm spot = up to 240 J/cm2
7mm spot = 15-100 J/cm2
10mm spot = 15-50 J/cm2 |
| Pulse duration | 0.5 - 60ms | 0.5 to 90 ms |
| Repetition
rate | 1,2,3, 5 for LP | Single shot to 10Hz |
| Delivery
system | Removable tips | Permanently attached handpiece with inserts |
| Spot size | 3,5,7,8mm | 1.5-10mm |
| Aiming beam | red | red |
| Footswitch | Yes | Yes |
| Console
dimensions | 176 cm x 29 cm x 86 cm (top
height of articulated arm) (66.3"
x 11.42" x 34") | Not known |
| Weight | 75 kg. / 165.4 lbs. | Not known |
| Indications
for Use | For the coagulation and
hemostasis of benign vascular
lesions such as, but not limited
to, port wine stains,
hemangiomas, warts,
telangiectasia, rosacea, venus
lake, leg veins, and spider veins.
2. The Alma Q laser system is
also indicated for the treatment
of wrinkles. 3. The Alma Q is
also indicated for the removal of
unwanted hair and for the
treatment of pseudofolliculitis
barbae (PFB). 4. The Alma Q
laser system is indicated for use
on all skin types (Fitzpatrick
IVI), including tanned skin. 5.
The intended use of the integral
cooling system in the Alma Q
laser handpiece is to provide
cooling of the skin prior to laser
treatment, for the reduction of
pain during laser treatment, to
allow for the use of higher
fluences for laser treatments
such as hair removal and
benign vascular lesions, and
to reduce the potential side
effects of laser treatments. | For the coagulation and hemostasis of benign
vascular lesions such as, but not limited to, port
wine stains, hemangiomas, warts, telangiectasia,
rosacea, venus lake, leg veins, and spider veins.
2. The MYDON C laser system is also indicated
for the treatment of wrinkles. 3. The MYDON C
is also indicated for the removal of unwanted hair
and for the treatment of pseudofolliculitis barbae
(PFB). 4. The MYDON C laser system is
indicated for use on all skin types (Fitzpatrick
IVI), including tanned skin. 5. The intended use
of the integral cooling system in the MYDON C
laser handpiece is to provide cooling of the skin
prior to laser treatment, for the reduction of pain
during laser treatment, to allow for the use of
higher fluences for laser treatments such as hair
removal and vascular lesions, and to reduce the
potential side effects of laser treatments. |
Alma Q LP 1064nm Substantial Equivalence Table
Premarket Notification, Traditional 510(k) Section 8: Page 4
8
Alma Q QS 1064nm Substantial Equivalence Table
| Characteristic | Alma Q | Naturalase K992597 |
|---|---|---|
| Laser | ||
| wavelength | QS 1064nm | QS 1064nm |
| Pulse width | 7ns | (6-8ns) |
| Light source | Solid state | Solid state |
| Repetition (Hz) | 1,2,5,10 Hz | 1,2,5,10 Hz |
| Max Output | ||
| energy | 1800mJ | 1800mJ |
| Fluence | 2mm - 57.32 J/cm2 | |
| 3mm - 25.5 J/cm2 | ||
| 4mm - 14.3 J/cm2 | ||
| 5mm - 9.17 J/cm2 | ||
| 6mm - 6.4 J/cm2 | ||
| 7mm - 4.7 J/cm2 | ||
| 8mm - 3.6 J/cm2 | 2mm - 57.32 J/cm2 | |
| 3mm - 25.5 J/cm2 | ||
| 4mm - 14.3 J/cm2 | ||
| 5mm - 9.17 J/cm2 | ||
| 6mm - 6.4 J/cm2 | ||
| 7mm - 4.7 J/cm2 | ||
| 8mm - 3.6 J/cm2 | ||
| 9mm - NA | ||
| 10mm - NA | ||
| Spot Size | 3-7mm | |
| 8mm collimated | 3 - 10mm | |
| Operation mode | Single shot, continuous | Single shot |
| Aiming beam | Red. Variable intensity | red |
| Footswitch | Yes | Yes |
| Characteristic | Alma Q | Naturalase K992597 |
| Console | ||
| dimensions | 176 cm x 29 cm x 86 cm (top | |
| height of articulated arm) | ||
| (66.3" x 11.42" x 34") | 124cm x 43cm x 66cm | |
| (50"x17"x27") | ||
| Weight | 75 kg. / 165.4 lbs | 125Kg./275lbs. |
| Articulated arm | Yes | Yes |
| Electrical | ||
| requirements | 230 VAC, 13A, 50/60 Hz, | |
| single phase | AC 230 V, 50/60 Hz | |
| Indications for | ||
| Use | The Alma Q laser | |
| treatment system is | ||
| intended for use: |
For the removal or lightening
of unwanted facial or body
hair.
For skin resurfacing
(ablation of epidermal skin
layers) in dermatology and
aesthetic surgery,
Dermal benign pigmented
lesions (dermal
melanocytosis); and
For tattoo removal (dark
and blue inks). | The Lorad LT-100 laser
treatment system is intended
for use:
Alone or in conjunction with
an adjuvant lotion for the
removal or lightening of
unwanted facial or body hair.
One or two treatments may be
required for lightening or
removing unwanted hair
without the adjuvant lotion;
In combination with the
adjuvant lotion for skin
resurfacing (ablation of
epidermal skin layers) in
dermatology and aesthetic
surgery,
Dermal pigmented lesions
(dermal melanocytosis);
and
For tattoo removal (dark and
blue inks).
The adjuvant lotion is a
suspension of carbon powder
in a base of Light Mineral Oil,
NF |
| Characteristic | Alma Q - Proposed | Naturalase K032667 |
| Laser | QS 532 | 532nm |
| wavelength | | |
| Pulse width | 7ns | (6-8ns) |
| Light source | Solid state | Solid state |
| Repetition (Hz) | 1,2,5,10 Hz | 1,2,5,10 Hz |
| Max Output
energy | Single-Pulse:
50-450mJ
Double-Pulse:
350-700mJ | 900 mJ |
| Fluence | 2mm - 22.3 J/cm2
3mm - 9.9 J/cm2
4mm - 5.6 J/cm2
5mm - 3.7J/cm2
6mm - 2.5 J/cm2
7mm - 1.8 J/cm2
8mm - 1.4 J/cm2 | 2mm - 28.66 J/cm2
3mm - 12.74 J/cm2
4mm - 7.17 J/cm2
5mm - 4.59 J/cm2
6mm - 3.18 J/cm2
7mm - 2.34 J/cm2
8mm - 1.79 J/cm2
9mm - NA |
| Spot Size | 2-7mm
8mm collimated | 2mm-9mm |
| Operation mode | Single shot, double shot | Single shot |
| Aiming beam | Red, variable intensity | red |
| Footswitch | Yes | Yes |
| Articulated arm | Yes | Yes |
| Electrical | 230 VAC, 13A, 50/60 Hz,
single phase | 220v, single phase, 8 amp |
| requirements | | |
| Console | 176 cm x 29 cm x 86 cm (top
height of articulated arm)
(66.3" x 11.42" x 34") | 124cm x 43cm x 66cm
(50" x 17" x 27") |
| dimensions | | |
| Weight | 75 kg. / 165.4 lbs. | 125Kg/275 lbs. |
9
10
Alma Q QS532 Substantial Equivalence Table
11
| Indications for Use | ||
|---|---|---|
| Tattoo removal | Tattoo removal | |
| Red inks | Red inks (532 nm Hand Piece Adapter) | |
| Blue and light blue inks | Blue and light blue inks (Yellow Dye Pack) | |
| Green inks | Green inks (Red Dye Pack) | |
| Treatment of Benign Vascular | Treatment of Vascular Lesions - 532 nm | |
| Lesions Port wine birthmark | Hand Piece Accessory Port wine birthmark | |
| Telangiectasias | Telangiectasias | |
| Spider angiomas | Spider angiomas | |
| Cherry angiomas | Cherry angiomas | |
| Spider nevi | Spider nevi | |
| Treatment of Benign | Treatment of Pigmented Lesions - 532 nm | |
| Pigmented Lesions - | Hand Piece Accessory | |
| Cafe-au-lait birthmarks Solar | Cafe-au-lait birthmarks Solar lentigines | |
| lentigines | Solar lentigines | |
| Solar lentigines | Becker's nevi | |
| Becker's nevi | Freckles | |
| Freckles | Nevus spilus | |
| Nevus spilus | Nevus of ota | |
| Nevus of ota | ||
| Incision, excision, ablation, and vaporization | ||
| Incision, excision, ablation, | of soft tissue in general dermatology. | |
| and vaporization of soft tissue | ||
| in general dermatology | ||
VII. Performance Testing [21 CFR 807.92(b)(1)]
IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance
IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard: Usability
IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1 Safety of laser products-Part 1: Equipment Classification, requirements and user's guide
IEC 62304 Medical device software - Software life cycle processes
In addition software verification and validation testing was performed and biocompatibility was established.
Premarket Notification, Traditional 510(k)
12
In all instances, the Alma Q Laser functioned as intended and the results observed were as expected.
VIII. Clinical Data [21 CFR 807.92(b) (2)]
Based on the similarities in the safety and effectiveness profiles of the subject and predicate devices, no animal or clinical studies were deemed needed to support this submission.
IX. Conclusions Safety and Effectiveness SE [21 CFR 807.92(b) (3)]
The Alma Q Laser is as safe and effective as the predicate devices Mydon and Naturalase (K040384, and K992597/K032667 respectively). The proposed subject device has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the subject and its predicate devices raise no new issues of safety or effectiveness. Thus, the Alma Q Laser is substantially equivalent.