Family of CoolGlide Aesthetic Lasers

K153671 · Cutera, Inc. · GEX · Mar 9, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153671
• Device Name: Family of CoolGlide Aesthetic Lasers
• Applicant: Cutera, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cutera Family of CoolGlide Aesthetic Lasers is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

Device Story

Family of CoolGlide Aesthetic Lasers utilizes laser and non-laser light sources (755 nm Alexandrite, 1064 nm Nd:YAG, 532 nm Nd:YAG, and 500-1300 nm pulsed light) to perform selective photothermolysis of target chromophores. System consists of console, footswitch, and interchangeable handpieces (including integral skin cooling). Operated by clinicians in dermatology, plastic surgery, and general surgery settings. Device delivers light energy to skin or soft tissue; cooling system protects epidermis, reduces pain, and allows higher fluences. Output enables hair reduction, vascular/pigmented lesion treatment, wrinkle reduction, and surgical soft tissue management. Clinical decision-making relies on clinician visual assessment of target lesions or tissue and selection of appropriate wavelength/fluence parameters.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including IEC 60601-1 and IEC 60601-1-2 safety standards, and software verification and validation.

Technological Characteristics

Flashlamp-pumped solid-state laser system. Wavelengths: 755 nm (Alexandrite), 1064 nm (Nd:YAG), 532 nm (Nd:YAG), 500-1300 nm (pulsed light). Integral skin cooling system. User interface: push-button or LCD color touchscreen. Delivery: non-sterile, reusable, cleanable handpieces. Safety standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for temporary and permanent hair reduction (all skin types I-VI, including tanned); treatment of benign pigmented lesions; treatment of wrinkles; photocoagulation/hemostasis of benign vascular lesions (e.g., port wine stains, hemangiomas, telangiectasias, rosacea, leg veins, poikiloderma of civatte); treatment of benign cutaneous lesions (e.g., warts, scars, striae, psoriasis, skin tags, keratoses, tattoos); treatment of pseudofolliculitis barbae; reduction of red pigmentation in hypertrophic/keloid scars; treatment of mild to moderate inflammatory acne vulgaris; and surgical incision, excision, cutting, ablation, and coagulation of soft tissue in various medical specialties including endoscopy/laparoscopy, ENT, neurosurgery, and gynecology.

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

• Family of CoolGlide Aesthetic Lasers (K132185)
• Family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Handpiece (K023954)
• Aerolase Model Nd:YAG 1064 nm Laser (K120235)
• Fotona Dynamis Pro Family (K143723)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 9, 2016

Cutera, Inc. Ms. Julia Brown Manager, Regulatory Affairs 3240 Bayshore Blvd. Brisbane, California 94005

Re: K153671

Trade/Device Name: Family Of Coolglide Aesthetic Lasers 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: December 18, 2015 Received: December 21, 2015

Dear Ms. Julia Brown:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

{1}------------------------------------------------

related 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 yours.

# Jennifer R. Stevenson -A

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) K153671

Device Name Family of CoolGlide Aesthetic Lasers

#### Indications for Use (Describe)

The Cutera Family of CoolGlide Aesthetic Lasers is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

755 nm:

The Family of CoolGlide Aesthetic Lasers is indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.

The Family of CoolGlide Aesthetic Lasers is also indicated for:

- · treatment of benign pigmented lesions
• treatment of wrinkles

· photocoagulation of dermatological vascular lesions, such as, but not limited to, port wine stains, hemangiomas and telangiectasias

#### 1064 nm:

Dermatology:

The Family of CoolGlide Aesthetic Lasers is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scriae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lessons, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.

Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

The CoolGlide lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.

The CoolGlide lasers are indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.

The CoolGlide lasers are also indicated for the treatment for pseudofolliculitis barbae (PFB).

The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The lasers are also indicated for treatment of mild to moderate inflammatory acne vulgaris.

The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The intended use of the integral cooling system in the CoolGlide laser handpiece is to provide cooling of the skin prior to

{3}------------------------------------------------

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.

#### Surgical Applications:

The lasers are indicated for the incision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neckl otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia), and urology.

#### 532 nm:

For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening. blanching, flattening, reduction of lesion size).

Optional Pulsed Light Handpiece:

For the treatment of benign pigmented lesions.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

This 510(k) Summary of Safety and Effectiveness for the Family of CoolGlide Aesthetic Lasers is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) Summary.

| Applicant: | Cutera, Inc. |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 3240 Bayshore Blvd.<br>Brisbane, CA 94005 |
| Contact Person: | Julia Brown |
| Telephone:<br>Fax:<br>Email: | 415-657-5575 – phone<br>415-715-3575 – fax<br>[e-mail] |
| Preparation Date: | December 18, 2015 |
| Device Trade Name: | Family of CoolGlide Aesthetic Lasers |
| Device Common Name: | Dermatology Laser |
| Device Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878.4810 |
| Legally Marketed Predicate<br>Device: | Family of CoolGlide Aesthetic Lasers (K132185)<br>Family of Altus Medical CoolGlide Aesthetic Lasers with<br>Optional Pulsed Light Handpiece (K023954)<br>Aerolase Model Nd:YAG 1064 nm Laser (K120235)<br>Fotona Dynamis Pro Family (K143723) |
| Description of the Family of<br>CoolGlide Aesthetic Lasers: | The Cutera Family of CoolGlide Aesthetic Lasers comprises<br>a variety of laser and non-laser light sources, including<br>single wavelength (755 nm Alexandrite, 1064 nm Nd:YAG or<br>532 nm Nd:YAG), multiple wavelength, pulsed light, and<br>laser/pulsed light combination models. The Family of<br>CoolGlide Aesthetic Lasers treats a wide range of<br>dermatologic conditions requiring selective photothermolysis<br>of target chromophores.<br>The Family of CoolGlide Aesthetic Lasers consists of a<br>system console, permanently attached laser handpiece,<br>footswitch, handpiece resting tree, and detachable pulsed<br>light handpieces. |

{5}------------------------------------------------

Intended use of The Family of The Family of CoolGlide Aesthetic Lasers is intended for CoolGlide Aesthetic Lasers: use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

Specific Indications:

#### 755 nm:

The Family of CoolGlide Aesthetic Lasers is indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.

The Family of CoolGlide Aesthetic Lasers is also indicated for:

- · treatment of benign pigmented lesions
- treatment of wrinkles
- · photocoagulation of dermatological vascular lesions. such as, but not limited to, port wine stains, hemangiomas and telangiectasias

#### 1064 nm:

#### Dermatology:

The Family of CoolGlide Aesthetic Lasers is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.

Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

The CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The CoolGlide lasers are indicated for temporary and permanent hair reduction. Permanent hair reduction is

{6}------------------------------------------------

defined as long-term, stable reduction in hair counts observed at 6. 9. and 12 months after the end of a treatment regime.

The CoolGlide lasers are also indicated for the treatment for pseudofolliculitis barbae (PFB).

The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The lasers are also indicated for treatment of mild to moderate inflammatory acne vulgaris.

The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The intended use of the integral cooling system in the CoolGlide 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.

### Surqical Applications:

The lasers are indicated for the incision/excision and cutting. ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia), and urology.

# 532 nm:

For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas. hemangiomas (port wine), telangiectasias (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, caféau-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

# Optional Pulsed Light Handpiece:

For the treatment of benign pigmented lesions.

{7}------------------------------------------------

| Performance Data: | IEC 60601-1 Medical Electrical Equipment - Part 1: General<br>Requirements for Safety |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| | IEC 60601-1-2 Medical Electrical Equipment 1-2 General<br>Requirements for basic safety and essential performance |
| | Software Verification and Validation Testing Report<br>V0066 rC Excel HR- Production V&V 2.1.0 |
| Results of Clinical Study: | None |
| Summary of Technological<br>Characteristics: | See below |

{8}------------------------------------------------

# Table 5—Technical Specification Comparison

| | Family of CoolGlide<br>Aesthetic Lasers<br>(new submission) | Family of CoolGlide<br>Aesthetic Lasers<br>(K132185) | Family of Altus Medical<br>CoolGlide Aesthetic Lasers<br>with Optional Pulsed Light<br>Handpiece (K023954) | Aerolase Model Nd:YAG<br>1064nm Laser<br>(K120235) | Fotona Dynamis Pro Family<br>(K143723) |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------|
| Wavelength(s) | 755 nm Alexandrite laser<br>1064 nm Nd:YAG laser<br>532 nm Nd:YAG laser<br>500-1300 nm pulsed light | 755 nm Alexandrite laser<br>1064 nm Nd:YAG laser<br>532 nm Nd: YAG laser<br>500–1300 nm pulsed light | 1064 nm Nd:YAG laser<br>532 nm Nd:YAG laser<br>500-1300 nm pulsed light | 1064 nm Nd:YAG laser | 1064 nm Nd:YAG laser |
| Spot Size | 755 nm: 5–18 mm<br>1064 nm: 3–18 mm<br>532 nm: 2–12 mm<br>500–1300 nm: 30 x 10 mm | 755 nm: 5, 8, 10, 12, 15, and 18 mm<br>1064 nm: 3, 5, 8, 10, and 12 mm<br>532 nm: 2–12 mm<br>500-1300 nm: 30 x 10 mm | 1064 nm: 0.1-50 mm<br>532 nm: 0.1-50 mm<br>500–1300 nm: 30 x 10 mm | 1 mm (for podiatry); ≤13 mm<br>(for other indications) | 3, 6, and 9 mm |
| Output Mode | Pulsed | Pulsed | Pulsed | Pulsed | Pulsed |
| Repetition<br>Rate | 755 nm: ≤2 Hz and single shot<br>1064 nm: ≤10 Hz and single shot<br>532 nm: ≤4 Hz and single shot<br>500-1300 nm: ≤1 Hz and single<br>shot | 755 nm: ≤2 Hz and single shot<br>1064 nm: ≤10 Hz and single shot<br>532 nm: ≤4 Hz and single shot<br>500-1300 nm: ≤1 Hz and single<br>shot | 1064 nm: ≤100 Hz and single shot<br>532 nm: ≤100 Hz and single shot<br>500–1300 nm: ≤1 Hz and single<br>shot | 5-100 Hz | ≤100 Hz |
| Laser Media | Flashlamp-pumped solid<br>state rod | Flashlamp-pumped solid<br>state rod | Flashlamp-pumped solid<br>state rod | Flashlamp-pumped solid<br>state rod | Flashlamp-pumped solid<br>state rod |
| User Interface | Push button control or LCD color<br>touchscreen | Push button control or LCD color<br>touchscreen | Push button control or LCD color<br>touchscreen | LCD color touchscreen | LCD color touchscreen |
| Aiming Beam | 755 nm: 630-680 nm<br>1064 nm: 630-680 nm<br>532 nm: 630-680 nm<br>500-1300 nm: none | 755 nm: 630-680 nm<br>1064 nm: 630-680 nm<br>532 nm: 630-680 nm<br>500-1300 nm: none | 1064 nm: 630-680 nm<br>532 nm: 630-680 nm<br>500-1300 nm: none | 630-680 nm | 650 nm |
| Delivery<br>Devices (How<br>Supplied) | Non-sterile, reusable,<br>cleanable | Non-sterile, reusable,<br>cleanable | Non-sterile, reusable,<br>cleanable | Non-sterile, reusable,<br>cleanable | Non-sterile, reusable,<br>cleanable |

{9}------------------------------------------------

Conclusion: Based on a comparison of technical specifications, intended uses, and indications for use, the Family of CoolGlide Aesthetic Lasers has been shown to be substantially equivalent to the previously cleared Family of CoolGlide Aesthetic Lasers (K132185), Family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Handpiece (K023954); Aerolase Model Nd:YAG 1064 nm Laser (K120235); Fotona Dynamis Pro Family (K143723).