FAMILY OF COOLGLIDE AESTHETIC LASERS
Device Facts
| Record ID | K132185 |
|---|---|
| Device Name | FAMILY OF COOLGLIDE AESTHETIC LASERS |
| Applicant | Cutera, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Dec 6, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The 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 comprises laser and non-laser light sources (755 nm Alexandrite, 1064 nm Nd:YAG, 532 nm Nd:YAG, 500-1300 nm pulsed light). System includes console, laser handpiece, footswitch, and optional pulsed light handpieces. Operates via selective photothermolysis of target chromophores; integral thermoelectric cooling system provides skin cooling to reduce pain and side effects, allowing higher fluences. Used in clinical settings by healthcare providers for dermatologic and surgical procedures. Output is controlled laser/light energy delivered to tissue; provider monitors treatment via visual inspection of tissue response. Benefits include hair reduction, lesion treatment, and surgical soft tissue management.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, technical specification comparisons, and software verification/validation.
Technological Characteristics
Flashlamp-pumped solid-state laser system. Wavelengths: 755 nm, 1064 nm, 532 nm, and 500-1300 nm pulsed light. Features full-contact thermoelectric skin cooling. User interface via push-button or LCD color touchscreen. Activation via footswitch. Non-sterile, reusable handpieces. Complies with IEC 60601-1 and 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, wrinkles, and photocoagulation of dermatological vascular lesions (e.g., port wine stains, hemangiomas, telangiectasias). Also indicated for coagulation/hemostasis of vascular lesions (e.g., rosacea, venous lake, leg veins, spider veins, poikiloderma of civatte), treatment of benign cutaneous lesions (e.g., warts, scars, striae, psoriasis, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, plaques, tattoos), pseudofolliculitis barbae, and reduction of red pigmentation in hypertrophic/keloid scars. Surgical applications include incision, excision, cutting, ablation, and coagulation/hemostasis of soft tissue in endoscopy/laparoscopy, gastroenterology, general surgery, ENT, neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology, and urology.
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 Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Handpiece (K023954)
- Candela GentleMAX Family of Laser Systems (K112715)
Submission Summary (Full Text)
{0}------------------------------------------------
DEC 0 6 2013
Image /page/0/Picture/1 description: The image shows the word "CUTERA" in a stylized font. The letters are composed of small dots or circles, giving them a textured appearance. The word appears to be a logo or brand name.
SAN FRANCIE Co. HEADCHARER 3 3240 Kavahore Boulevard, Studiatu: CA 74005 Phone: 41.2-1.57-5.5500 | Paz: 41.3.36-24.44 | www.cuters.com
## Attachment 5 510(K) Summary Family of CoolGlide Aesthetic Lasers
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. Brisbane, CA 94005
415-657-5526 - phone
shansen@cutera.com
415-715-3526 - fax
December 3, 2013
Contact Person:
Sandra Hansen
Telephone: Fax: Email:
Preparation Date:
Device Trade Name:
Dermatology Laser Common Name:
Classification Name:
Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878-48
Family of CoolGlide Aesthetic Lasers
Legally Marketed Predicate Family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Handpiece (K023954) Device: Candela GentleMAX Family of Laser Systems (K112715)
Description of the Family of CoolGlide Aesthetic Lasers: The Cutera Family of CoolGlide Aesthetic Lasers comprises a variety of laser and non-laser light sources, including single wavelength (755 nm Alexandrite, 1064 nm Nd:YAG or 532 nm Nd:YAG), multiple wavelength, pulsed light, and laser/pulsed light combination models. The Family of CoolGlide Aesthetic Lasers treats a wide range of dermatologic conditions requiring selective photothermolysis of target chromophores.
The Family of CoolGlide Aesthetic Lasers consists of a system console, permanently attached laser handpiece, footswitch, handpiece resting tree, and detachable pulsed light handpieces.
{1}------------------------------------------------
The Family of CoolGlide Aesthetic Lasers is intended for Intended use of The Family of 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, hemanqiomas, 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.
{2}------------------------------------------------
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 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.
#### Surgical 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/otorhinolarvngology (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; cutaneous lesion treatment
{3}------------------------------------------------
(hemostasis, color lightening, blanching, flattening, reduction of lesion size).
## Optional Pulsed Light Handpiece:
For the treatment of benign pigmented lesions.
IEC 60601-1 Medical Electrical Equipment - Part 1: General Performance Data: Requirements for Safety
> IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance
Software Verification and Validation Testing Reports V0066 r1 Alexandrite- Xeo 510K V&V 4.6.0 V0066 r2 Alexandrite- Xeo 510K V&V 5.0
Results of Clinical Study: None
of Technological See Below: Summary Characteristics:
{4}------------------------------------------------
## Technical Specification Comparison
| | Family of CoolGlide<br>Aesthetic Lasers | Candela GentleMAX Family<br>of Laser Systems (K112715)† | Family of Altus Medical CoolGlide<br>Aesthetic Lasers with Optional<br>Pulsed Light Handpiece (K023954) |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Wavelengths | 755 nm Alexandrite laser<br>1064 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 | 1064 Nd: YAG laser<br>532 nm Nd:YAG laser<br>500-1300 nm pulsed light |
| Fluence | 755 nm: 4-100 J/cm²<br>1064 nm: 3-300 J/cm²<br>532 nm: 1.8-42 J/cm²<br>500-1300 nm: 2-65 J/cm² | 755 nm: 3-100 J/cm²<br>1064 nm: 3-520 J/cm² | 1064 nm: ≤ 25,000 J/cm² (with 0.1 mm<br>spot)<br>532 nm: ≤ 25,000 J/cm² (with 0.1 mm<br>spot)<br>500-1300 nm: 2-65 J/cm² |
| Pulse Duration | 755 nm: 3 ms<br>1064 nm: 0.1-300 ms<br>532 nm: 1.5-40 ms<br>500-1300 nm: 0.5-100 ms | 755 nm: 0.25-100 ms<br>1064 nm: 0.25-100 ms | 1064 nm: ≤ 990 ms<br>532 nm: ≤ 990 ms<br>500-1300 nm: 0.5-100 ms |
| Spot Size | 755 nm: 5, 8, 10, 12, 15<br>and 18 mm<br>1064 nm: 3, 5, 8, 10 and<br>12 mm<br>532 nm: 2-12 mm<br>500-1300 nm: 30 x 10 mm | 755 nm: 1.5-24 mm<br>1064 nm: 1.5-24 mm | 1064 nm: 0.1-50 mm<br>532 nm: 0.1-50 mm<br>500-1300 nm: 30 x 10 mm |
| Output Mode | Pulsed | Pulsed | Pulsed |
| Repetition Rate | 755 nm: ≤ 2 Hz and single<br>shot<br>1064 nm: ≤ 10 Hz and<br>single shot<br>532 nm: ≤ 4 Hz and single<br>shot<br>500-1300 nm: ≤ 1 Hz and<br>single shot | 755 nm: ≤ 10 Hz and single<br>shot<br>1064 nm: ≤ 10 Hz and<br>single 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 |
| Laser Media | Flashlamp-pumped solid<br>state rod | Flashlamp-pumped solid state<br>rod | Flashlamp-pumped solid state rod |
| User Interface | Push button control or LCD<br>color touchscreen | Push button control or LCD<br>color touchscreen | Push button control or LCD color<br>touchscreen |
| Treatment Beam<br>Activation | Footswitch | Footswitch or fingerswitch | Footswitch |
| Skin Cooling | Full contact thermoelectric<br>chiller | Air cooling or optional<br>cryogen cooling | Full contact thermoelectric chiller |
| 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: 635-670 nm<br>1064 nm: 520-550 nm | 1064 nm: 630-680 nm<br>532 nm: 630-680 nm<br>500-1300 nm: none |
| Delivery Devices<br>(How Supplied) | Non-sterile, reusable,<br>cleanable | Non-sterile, reusable,<br>cleanable | Non-sterile, reusable, cleanable |
| Optional<br>Detachable<br>Handpieces | Yes | unknown | Yes |
↑ Candela technical specifications taken from GentleMAX product webpage (http://syneron-candela.com/na/product/gentle-pro-series/howitworks)
r
{5}------------------------------------------------
Based on performance testing results and a comparison of technical specifications, Conclusion: intended uses and indications for use, the Family of CoolGlide Aesthetic Lasers has been shown to be substantially equivalent to the Family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Handpiece (K023954) and to the Candela GentleMAX Family of Laser Systems (K112715).
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
## 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
Cutera Incorporated Ms. Sandra Hansen Regulatory Affairs Manager 3240 Bayshore Boulevard Brisbane, California 94005
December 6, 2013
Re: K132185
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: November 7, 2013 Received: November 8, 2013
Dear Ms. Hansen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we neversed 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 for use surve in the enorobard to the enactment date of the Medical Device Amendments, or to commerce provide way 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have boon roomsoniou in quire approval of a premarket approval application (PMA). and Costient rior (rec) that as novice, subject to the general controls provisions of the Act. The I ou may, therefore, manel of the Act include requirements for annual registration, listing of general controls provisions of the fice, labeling, and prohibitions against misbranding and action. 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 It inay be subject to additions, 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 Please be auvised that I Dri 3 issualled or our device complies with other requirements of the Act that IDA has made a dolerinmation administered by other Federal agencies. You must or any rederal statutes and regulations annuting, but not limited to: registration and listing (2 l comply will an the Act 3 requirements (1): medical device reporting (reporting of medical Cr K Fall 807), labeling (21 OFR 803); good manufacturing practice requirements as set
{7}------------------------------------------------
Page 2 - Ms. Sandra Hansen
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
# Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
## Indications for Use
## 510(k) Number: K132185
Device Name: Family of CoolGlide Aesthetic Lasers
#### Indications For 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.
#### 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:
O treatment of benign pigmented lesions
#### 0 treatment of wrinkles
O 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 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.
| Prescription Use<br>_X_ | AND/OR | Over-The-Counter Use |
|-----------------------------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) |
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) Neil R Ogden - S 2013.12.06 08:59:33 -05 00
(Division Sign-Off) for BSA Division of Surgical Devices 510(k) Number _K132185
Page 1 of 2
{9}------------------------------------------------
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 (FFB).
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 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.
#### 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 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), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)); benign pigmented lesings [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size).
#### Optional Pulsed Light Handpiece:
For the treatment of benign pigmented lesions.
AND/OR Over-The-Counter Use Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Neil R Ogdens 2013.12.06 08:59:55 -05'00'
(Division Sign-Off) for BSA Division of Surgical Devices 510(k) Number___K132185
Page 2 of 2
