Alma Q

K170850 · Alma Lasers , Ltd. · GEX · Jun 15, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170850
• Device Name: Alma Q
• Applicant: Alma Lasers , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alma Q 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.

Device Story

Flash lamp pumped Nd:YAG laser system; emits 1064nm wavelength; incorporates frequency conversion technology (KTP crystal) for 532nm wavelength. Operates in Q-switched mode or long-pulsed mode. Transmits radiation via articulated arm with removable tips. Includes integral cooling system in handpiece to reduce skin temperature, pain, and side effects. Used in hospitals, physician offices, and medical spas by trained clinicians. Clinician selects parameters based on target tissue; laser energy induces photothermolysis, ablation, or vaporization. Output affects tissue via thermal interaction; cooling system allows higher fluences for hair removal and vascular treatments. Benefits include precise tissue management and reduced patient discomfort.

Clinical Evidence

No clinical data or animal studies were performed. Substantial equivalence is based on bench testing, including electrical safety, laser safety, usability, and software verification/validation.

Technological Characteristics

Flash lamp pumped Nd:YAG laser; 1064nm and 532nm wavelengths; KTP crystal frequency conversion; articulated arm delivery; integral cooling system. Materials: aluminum (limited-duration contact with intact skin). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, IEC 62304. Non-sterile, reusable.

Indications for Use

Indicated for coagulation/hemostasis of benign vascular lesions (port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins); treatment of wrinkles; removal of unwanted hair; treatment of pseudofolliculitis barbae (PFB); tattoo removal (red, blue, light blue, green, dark inks); treatment of benign pigmented lesions (cafe-au-lait, solar lentigines, Becker's nevi, freckles, nevus spilus, nevus of ota); and incision, excision, ablation, and vaporization of soft tissue. Indicated for all skin types (Fitzpatrick I-VI), including tanned skin.

Regulatory Classification

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.

Predicate Devices

• Mydon/Quantel Derma (K040384)
• Naturalase/Focus Medical (K032667)
• Naturalase/Focus Medical (K992597)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known)

K170850

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

- 1. 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.
- The Alma Q is also indicated for the removal of unwanted hair and for the treatment of 3. 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 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
- 1. Tattoo removal
- -Red inks
- -Blue and light blue inks
- -Green inks
- 2. Treatment of benign vascular lesions
- -Telangiectasias
- -Spider angiomas
- -Cherry angiomas
- -Spider nevi
- 3. Treatment of benign pigmented lesions
- -Cafe-au-lait birthmarks solar lentigines
- -Solar lentigines
- -Becker's nevi
- -Freckles
- -Nevus spilus
- -Nevus of ota
- 4. Incision, excision, ablation, and vaporization of soft tissue in general dermatology

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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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#### 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<br>Buffalo Grove, IL 60089 |
| Contact Person | Kathy Maynor<br>Regulatory Consultant<br>Email : [e-mail]<br>Phone: [phone] |
| 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<br>Regulatory Class | Product<br>Code(s) | Classification Panel | Regulation |
| Laser Powered Surgical<br>Instruments (& Accessories)<br>Class II | GEX | General & Plastic<br>Surgery Panel, 79 (SU) | § 878.4810, Laser surgical<br>instrument for use in general and<br>plastic surgery and dermatology |
| | Surgical Powered Lasers and Delivery Devices/Hand piece<br>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

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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).
- 4. 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

1.

- Tattoo removal -Red inks -Blue and light blue inks -Green inks
- 2. Treatment of benign vascular lesions
- -Telangiectasias -Spider angiomas -Cherry angiomas
- -Spider nevi
- 3. Treatment of benign pigmented lesions -Cafe-au-lait birthmarks -Solar lentigines -Becker's nevi -Freckles

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-Nevus spilus -Nevus of ota

- 4. 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.

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| Characteristic | Alma Q | Mydon<br>(K040384) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wavelength | 1064nm | 1064nm |
| Output energy | 40J | 40J |
| Fluence | 10-450J/cm2<br>3.0mm spot = 30-300J/cm2<br>5mm spot = up to 240 J/cm2<br>7mm spot = 15-100 J/cm2<br>8mm collimated = up to 58J/cm2 | 10-450J/cm2<br>1.5mm spot = 160-450 J/cm2<br>3.0mm spot = 30-300J/cm2<br>5mm spot = up to 240 J/cm2<br>7mm spot = 15-100 J/cm2<br>10mm spot = 15-50 J/cm2 |
| Pulse duration | 0.5 - 60ms | 0.5 to 90 ms |
| Repetition<br>rate | 1,2,3, 5 for LP | Single shot to 10Hz |
| Delivery<br>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<br>dimensions | 176 cm x 29 cm x 86 cm (top<br>height of articulated arm) (66.3"<br>x 11.42" x 34") | Not known |
| Weight | 75 kg. / 165.4 lbs. | Not known |
| Indications<br>for Use | For the coagulation and<br>hemostasis of benign vascular<br>lesions such as, but not limited<br>to, port wine stains,<br>hemangiomas, warts,<br>telangiectasia, rosacea, venus<br>lake, leg veins, and spider veins.<br>2. The Alma Q laser system is<br>also indicated for the treatment<br>of wrinkles. 3. The Alma Q is<br>also indicated for the removal of<br>unwanted hair and for the<br>treatment of pseudofolliculitis<br>barbae (PFB). 4. The Alma Q<br>laser system is indicated for use<br>on all skin types (Fitzpatrick<br>IVI), including tanned skin. 5.<br>The intended use of the integral<br>cooling system in the Alma Q<br>laser handpiece is to provide<br>cooling of the skin prior to laser<br>treatment, for the reduction of<br>pain during laser treatment, to<br>allow for the use of higher<br>fluences for laser treatments<br>such as hair removal and<br>benign vascular lesions, and<br>to reduce the potential side<br>effects of laser treatments. | For the coagulation and hemostasis of benign<br>vascular lesions such as, but not limited to, port<br>wine stains, hemangiomas, warts, telangiectasia,<br>rosacea, venus lake, leg veins, and spider veins.<br>2. The MYDON C laser system is also indicated<br>for the treatment of wrinkles. 3. The MYDON C<br>is also indicated for the removal of unwanted hair<br>and for the treatment of pseudofolliculitis barbae<br>(PFB). 4. The MYDON C laser system is<br>indicated for use on all skin types (Fitzpatrick<br>IVI), including tanned skin. 5. The intended use<br>of the integral cooling system in the MYDON C<br>laser handpiece is to provide cooling of the skin<br>prior to laser treatment, for the reduction of pain<br>during laser treatment, to allow for the use of<br>higher fluences for laser treatments such as hair<br>removal and vascular lesions, and to reduce the<br>potential side effects of laser treatments. |

### Alma Q LP 1064nm Substantial Equivalence Table

Premarket Notification, Traditional 510(k) Section 8: Page 4

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# Alma Q QS 1064nm Substantial Equivalence Table

| Characteristic | Alma Q | Naturalase K992597 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Laser<br>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<br>energy | 1800mJ | 1800mJ |
| Fluence | 2mm - 57.32 J/cm2<br>3mm - 25.5 J/cm2<br>4mm - 14.3 J/cm2<br>5mm - 9.17 J/cm2<br>6mm - 6.4 J/cm2<br>7mm - 4.7 J/cm2<br>8mm - 3.6 J/cm2 | 2mm - 57.32 J/cm2<br>3mm - 25.5 J/cm2<br>4mm - 14.3 J/cm2<br>5mm - 9.17 J/cm2<br>6mm - 6.4 J/cm2<br>7mm - 4.7 J/cm2<br>8mm - 3.6 J/cm2<br>9mm - NA<br>10mm - NA |
| Spot Size | 3-7mm<br>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<br>dimensions | 176 cm x 29 cm x 86 cm (top<br>height of articulated arm)<br>(66.3" x 11.42" x 34") | 124cm x 43cm x 66cm<br>(50"x17"x27") |
| Weight | 75 kg. / 165.4 lbs | 125Kg./275lbs. |
| Articulated arm | Yes | Yes |
| Electrical<br>requirements | 230 VAC, 13A, 50/60 Hz,<br>single phase | AC 230 V, 50/60 Hz |
| Indications for<br>Use | The Alma Q laser<br>treatment system is<br>intended for use:<br><br>For the removal or lightening<br>of unwanted facial or body<br>hair.<br><br>For skin resurfacing<br>(ablation of epidermal skin<br>layers) in dermatology and<br>aesthetic surgery,<br><br>Dermal benign pigmented<br>lesions (dermal<br>melanocytosis); and<br><br>For tattoo removal (dark<br>and blue inks). | The Lorad LT-100 laser<br>treatment system is intended<br>for use:<br><br>Alone or in conjunction with<br>an adjuvant lotion for the<br>removal or lightening of<br>unwanted facial or body hair.<br>One or two treatments may be<br>required for lightening or<br>removing unwanted hair<br>without the adjuvant lotion;<br><br>In combination with the<br>adjuvant lotion for skin<br>resurfacing (ablation of<br>epidermal skin layers) in<br>dermatology and aesthetic<br>surgery,<br><br>Dermal pigmented lesions<br>(dermal melanocytosis);<br>and<br><br>For tattoo removal (dark and<br>blue inks).<br><br>The adjuvant lotion is a<br>suspension of carbon powder<br>in a base of Light Mineral Oil,<br>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<br>energy | Single-Pulse:<br>50-450mJ<br>Double-Pulse:<br>350-700mJ | 900 mJ |
| Fluence | 2mm - 22.3 J/cm2<br>3mm - 9.9 J/cm2<br>4mm - 5.6 J/cm2<br>5mm - 3.7J/cm2<br>6mm - 2.5 J/cm2<br>7mm - 1.8 J/cm2<br>8mm - 1.4 J/cm2 | 2mm - 28.66 J/cm2<br>3mm - 12.74 J/cm2<br>4mm - 7.17 J/cm2<br>5mm - 4.59 J/cm2<br>6mm - 3.18 J/cm2<br>7mm - 2.34 J/cm2<br>8mm - 1.79 J/cm2<br>9mm - NA |
| Spot Size | 2-7mm<br>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,<br>single phase | 220v, single phase, 8 amp |
| requirements | | |
| Console | 176 cm x 29 cm x 86 cm (top<br>height of articulated arm)<br>(66.3" x 11.42" x 34") | 124cm x 43cm x 66cm<br>(50" x 17" x 27") |
| dimensions | | |
| Weight | 75 kg. / 165.4 lbs. | 125Kg/275 lbs.…