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
O 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.
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.

Device Description

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.

AI/ML Overview

This document is a 510(k) Summary for the Cutera Family of CoolGlide Aesthetic Lasers, aiming to demonstrate substantial equivalence to predicate devices, not to prove that the device meets specific acceptance criteria through a clinical study with detailed performance metrics. The submission focuses on technical specification comparisons and indications for use.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment are not present in this document. The document explicitly states "Results of Clinical Study: None."

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with corresponding reported device performance metrics in the way one would expect from a clinical trial. Instead, it offers a "Technical Specification Comparison" against predicate devices to demonstrate equivalence, not a direct measurement against predefined acceptance thresholds for clinical efficacy.

Feature / Metric	Family of CoolGlide Aesthetic Lasers (New Device)	Acceptance Criteria (Implicit by Predicate)	Reported Device Performance (New Device)
Wavelengths	755 nm Alexandrite, 1064 Nd:YAG, 532 nm Nd:YAG, 500-1300 nm pulsed light	Match or be comparable to predicate devices	Aligns with predicate capabilities, offering additional wavelengths.
Fluence	755 nm: 4-100 J/cm²1064 nm: 3-300 J/cm²532 nm: 1.8-42 J/cm²500-1300 nm: 2-65 J/cm²	Comparable range to predicate devices (e.g., Candela 755nm: 3-100 J/cm², 1064nm: 3-520 J/cm²)	Within or exceeding ranges of predicate devices.
Pulse Duration	755 nm: 3 ms1064 nm: 0.1-300 ms532 nm: 1.5-40 ms500-1300 nm: 0.5-100 ms	Comparable range to predicate devices (e.g., Candela 755nm: 0.25-100 ms, 1064nm: 0.25-100 ms)	Within or exceeding ranges of predicate devices.
Spot Size	755 nm: 5, 8, 10, 12, 15 and 18 mm1064 nm: 3, 5, 8, 10 and 12 mm532 nm: 2-12 mm500-1300 nm: 30 x 10 mm	Comparable range to predicate devices (e.g., Candela 755nm: 1.5-24 mm, 1064nm: 1.5-24 mm)	Within or exceeding ranges of predicate devices.
Output Mode	Pulsed	Pulsed	Pulsed
Repetition Rate	755 nm: ≤ 2 Hz and single shot1064 nm: ≤ 10 Hz and single shot532 nm: ≤ 4 Hz and single shot500-1300 nm: ≤ 1 Hz and single shot	Comparable range to predicate devices (e.g., Candela 755nm: ≤ 10 Hz and single shot, 1064nm: ≤ 10 Hz and single shot)	Within or comparable to ranges of predicate devices.
Laser Media	Flashlamp-pumped solid state rod	Flashlamp-pumped solid state rod	Flashlamp-pumped solid state rod
User Interface	Push button control or LCD color touchscreen	Push button control or LCD color touchscreen	Push button control or LCD color touchscreen
Treatment Beam Activation	Footswitch	Footswitch or fingerswitch	Footswitch, comparable to predicate.
Skin Cooling	Full contact thermoelectric chiller	Air cooling or optional cryogen cooling (Candela) / Full contact thermoelectric chiller (Altus)	Uses full contact thermoelectric chiller, similar to one predicate.
Aiming Beam	755 nm: 630-680 nm1064 nm: 630-680 nm532 nm: 630-680 nm500-1300 nm: none	Comparable to predicate devices (e.g., Candela 755nm: 635-670 nm, 1064nm: 520-550 nm)	Within or comparable to range of predicate devices.
Delivery Devices	Non-sterile, reusable, cleanable	Non-sterile, reusable, cleanable	Non-sterile, reusable, cleanable
Optional Detachable Handpieces	Yes	Yes (Altus), Unknown (Candela)	Yes

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable and not provided. The submission states, "Results of Clinical Study: None." The assessment is based on technical specifications and comparison to predicate devices, not a clinical test set.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no clinical study defining a test set or ground truth was conducted for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical study or test set requiring adjudication was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable and not provided. This is a laser device, not an AI-assisted diagnostic tool, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable and not provided. This device is a physical laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable as no clinical study or ground truth establishment was conducted. The "truth" for this submission is the established performance and indications of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable and not provided. No machine learning or an algorithm requiring a training set is described in this submission.

9. How the ground truth for the training set was established

Not applicable as no training set or ground truth for such a set was established.

Summary of the Study (as described in the document):

The "study" presented here is a technical and regulatory comparison rather than a traditional clinical study. The manufacturer, Cutera, Inc., submitted a 510(k) Premarket Notification to demonstrate that their "Family of CoolGlide Aesthetic Lasers" is substantially equivalent to two legally marketed predicate devices:

Family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Handpiece (K023954)
Candela GentleMAX Family of Laser Systems (K112715)

The equivalence is based on:

Performance Testing Results: While not detailed in this summary, the document mentions "performance testing results" in its conclusion. These likely refer to engineering and functional tests to confirm the device operates according to its specifications, rather than clinical efficacy trials.
Comparison of Technical Specifications: A detailed table comparing wavelengths, fluence, pulse duration, spot size, output mode, repetition rate, laser media, user interface, aiming beam, delivery devices, and skin cooling methods between the new device and the predicates.
Comparison of Intended Uses and Indications for Use: The new device's indications for use were shown to be similar to or a superset of those of the predicate devices.

Conclusion stated in the document:
"Based on performance testing results and 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 Family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Handpiece (K023954) and to the Candela GentleMAX Family of Laser Systems (K112715)."

Summary

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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.

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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:

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Technical Specification Comparison

	Family of CoolGlideAesthetic Lasers	Candela GentleMAX Familyof Laser Systems (K112715)†	Family of Altus Medical CoolGlideAesthetic Lasers with OptionalPulsed Light Handpiece (K023954)
Wavelengths	755 nm Alexandrite laser1064 Nd:YAG laser532 nm Nd:YAG laser500-1300 nm pulsed light	755 nm Alexandrite laser1064 nm Nd:YAG laser	1064 Nd: YAG laser532 nm Nd:YAG laser500-1300 nm pulsed light
Fluence	755 nm: 4-100 J/cm²1064 nm: 3-300 J/cm²532 nm: 1.8-42 J/cm²500-1300 nm: 2-65 J/cm²	755 nm: 3-100 J/cm²1064 nm: 3-520 J/cm²	1064 nm: ≤ 25,000 J/cm² (with 0.1 mmspot)532 nm: ≤ 25,000 J/cm² (with 0.1 mmspot)500-1300 nm: 2-65 J/cm²
Pulse Duration	755 nm: 3 ms1064 nm: 0.1-300 ms532 nm: 1.5-40 ms500-1300 nm: 0.5-100 ms	755 nm: 0.25-100 ms1064 nm: 0.25-100 ms	1064 nm: ≤ 990 ms532 nm: ≤ 990 ms500-1300 nm: 0.5-100 ms
Spot Size	755 nm: 5, 8, 10, 12, 15and 18 mm1064 nm: 3, 5, 8, 10 and12 mm532 nm: 2-12 mm500-1300 nm: 30 x 10 mm	755 nm: 1.5-24 mm1064 nm: 1.5-24 mm	1064 nm: 0.1-50 mm532 nm: 0.1-50 mm500-1300 nm: 30 x 10 mm
Output Mode	Pulsed	Pulsed	Pulsed
Repetition Rate	755 nm: ≤ 2 Hz and singleshot1064 nm: ≤ 10 Hz andsingle shot532 nm: ≤ 4 Hz and singleshot500-1300 nm: ≤ 1 Hz andsingle shot	755 nm: ≤ 10 Hz and singleshot1064 nm: ≤ 10 Hz andsingle shot	1064 nm: ≤ 100 Hz and single shot532 nm: ≤ 100 Hz and single shot500-1300 nm: ≤ 1 Hz and singleshot
Laser Media	Flashlamp-pumped solidstate rod	Flashlamp-pumped solid staterod	Flashlamp-pumped solid state rod
User Interface	Push button control or LCDcolor touchscreen	Push button control or LCDcolor touchscreen	Push button control or LCD colortouchscreen
Treatment BeamActivation	Footswitch	Footswitch or fingerswitch	Footswitch
Skin Cooling	Full contact thermoelectricchiller	Air cooling or optionalcryogen cooling	Full contact thermoelectric chiller
Aiming Beam	755 nm: 630-680 nm1064 nm: 630-680 nm532 nm: 630-680 nm500-1300 nm: none	755 nm: 635-670 nm1064 nm: 520-550 nm	1064 nm: 630-680 nm532 nm: 630-680 nm500-1300 nm: none
Delivery Devices(How Supplied)	Non-sterile, reusable,cleanable	Non-sterile, reusable,cleanable	Non-sterile, reusable, cleanable
OptionalDetachableHandpieces	Yes	unknown	Yes

↑ Candela technical specifications taken from GentleMAX product webpage (http://syneron-candela.com/na/product/gentle-pro-series/howitworks)

{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:

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 UseX	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 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.

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

Regulation Number and Section

§ 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.