Q-Switched Nd:YAG Laser System

K171079 · Ids, Ltd. · GEX · Aug 1, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171079
• Device Name: Q-Switched Nd:YAG Laser System
• Applicant: Ids, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Q10 Q-Switched Nd: YAG Laser System is indicated for incision, ablation and vaporization of soft tissue for general dermatology. 1064nm wavelength in Q-switched mode: - Removal of dark ink (black, blue and brown) tattoos - Treatment of nevus of Ota - Treatment of common nevus - Removal or lightening of unwanted hair - Skin resurfacing procedures for the treatment of acne scars and wrinkles 1064nm wavelength in non Q-switched mode: - Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9, and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin - Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins - Coagulation and hemostasis of soft tissue - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris 532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece): - Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos - Treatment of vascular lesions including, but not limited to: - port wine birthmarks - telangiectasias - spider angioma - cherry angioma - spider nevus - Treatment of pigmented lesions including, but not limited to: - café-au-lait birthmarks - solar lentigines - senile lentigines - Becker's nevus - freckles - common nevus - nevus spilus - Treatment of seborrheic keratosis - Treatment of post inflammatory hyperpigmentation - Skin resurfacing procedures for the treatment of acne scars and wrinkles

Device Story

Q-Switched Nd:YAG laser system; delivers 1064nm and 532nm wavelengths (with optional 585nm/650nm dye hand-pieces). Operates in Q-switched or non-Q-switched modes for varied dermatological applications including tattoo removal, hair reduction, vascular/pigmented lesion treatment, and skin resurfacing. Used in clinical settings by trained healthcare professionals. Laser energy interacts with target tissues (ink, hair follicles, vascular structures) via photocoagulation, hemostasis, or ablation. Output is controlled by the clinician to achieve therapeutic effects on skin and soft tissue. Benefits include non-invasive or minimally invasive management of dermatological conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Q-Switched Nd:YAG laser; 1064nm and 532nm wavelengths; optional 585nm/650nm dye hand-pieces. Operates in Q-switched and non-Q-switched modes. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for soft tissue incision, ablation, and vaporization in general dermatology. Patient population includes individuals requiring tattoo removal, hair removal (all skin types), treatment of pigmented/vascular lesions, acne, wrinkles, and scars.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, arranged in a way that they resemble a bird in flight. The profiles are depicted in a simple, line-art style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 1, 2017

IDS, Ltd. % Alexander Henderson Official Correspondent, IDS BraunSolutions 970 South Dawson Way Unit 14 Aurora, Colorado 80012-3827

Re: K171079

Trade/Device Name: Q-Switched Nd:YAG Laser System 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: May 2, 2017 Received: May 5, 2017

Dear Alexander Henderson:

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

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR 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 (QS) 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) K171079

#### Device Name

IDS Model Q10 Q-Switched Nd: YAG Laser

Indications for Use (Describe)

The Q10 Q-Switched Nd: YAG Laser System is indicated for incision, ablation and vaporization of soft tissue for general dermatology.

1064nm wavelength in Q-switched mode:

- Removal of dark ink (black, blue and brown) tattoos
- Treatment of nevus of Ota
- Treatment of common nevus
- Removal or lightening of unwanted hair
- Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064nm wavelength in non Q-switched mode:

- Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9, and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin

- Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains,

hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins

- Coagulation and hemostasis of soft tissue
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris

532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece):

- Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
- Treatment of vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angioma
- cherry angioma
- spider nevus
- Treatment of pigmented lesions including, but not limited to:
- café-au-lait birthmarks
- solar lentigines
- senile lentigines
- Becker's nevus
- freckles
- common nevus
- nevus spilus
- Treatment of seborrheic keratosis
- Treatment of post inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles

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Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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