CANDELA GENTLELASE FAMILY OF LASER SYSTEMS

K140732 · Candela Corp. · GEX · Nov 7, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140732
• Device Name: CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 7, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GentleLASE Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Device Story

The GentleLASE Family of Laser Systems (GentleLase Pro and GentleLase Pro LE) is a dermatology laser system utilizing an alexandrite laser head to emit 755 nm light. The device delivers laser energy to skin via an optical fiber delivery system; a Dynamic Cooling Device (DCD) provides cryogen bursts to protect the epidermis. Operated by clinicians in a professional setting, the device targets melanin in hair follicles or vascular/pigmented lesions to deliver therapeutic heat. The system is controlled via fingerswitch or footswitch. The output allows clinicians to perform hair reduction, lesion treatment, and wrinkle reduction. The device is a modification of the GentleMAX system, featuring identical technological principles and performance specifications, with the only physical difference being side panel color.

Clinical Evidence

No clinical data was required for these modifications. Performance was established via bench testing, including verification and validation of the software update and compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-22 standards.

Technological Characteristics

Flashlamp-excited, solid-state alexandrite laser; 755 nm wavelength; 3–300 ms pulse duration; max fluence 53 J/cm²; spot sizes 6–24 mm; max 2 Hz repetition rate. Cooling via self-contained internally circulated liquid-to-air system and cryogen DCD. Dimensions 42" x 18" x 27"; weight 250 lbs. Software-controlled.

Indications for Use

Indicated for temporary or permanent hair reduction on all skin types (Fitzpatrick I-VI, including tanned skin), treatment of benign pigmented lesions, treatment of wrinkles, and photocoagulation of dermatological vascular lesions (e.g., port-wine stains, hemangiomas, telangiectasias).

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

• GentleMAX Family of Laser Systems (K133283)

Submission Summary (Full Text)

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

November 7, 2014

Candela Corporation Mr. Sam Wade Vice President, Regulatory Affairs and Quality Assurance 530 Boston Post Road Wayland, Massachusetts 01778

Re: K140732

Trade/Device Name: GentleLASE Family of Laser Systems 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: October 9, 2014 Received: October 10, 2014

Dear Mr. Wade:

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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/Resourcesfor You/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 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,

# David Krause -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K140732

Device Name GentleLASE Family of Laser Systems

Indications for Use (Describe)

The GentleLASE Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias)

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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FORM FDA 3881 (1/14)

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# 510(k) Summary GentleLASE Family of Laser Systems

## General Information:

This Special 510(k) is to provide notification of a software change made for the modified GentleLASE Family of Laser Systems (GentleLase Pro and GentleLase Pro LE Laser Systems) to the previously cleared GentleMAX Family of Laser Systems (K133283) manufactured by Candela Corporation.

| Submitted by: | Candela Corporation<br>530 Boston Post Road<br>Wayland, MA 01778-1886 | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Sam Wade.<br>Vice President, Regulatory Affairs and Quality Assurance<br>Tel: [phone] x330<br>Fax: [phone] | |
| Date prepared: | March 14, 2014 | |
| Trade Name: | GentleLASE Family of Laser Systems | |
| Common Name: | Dermatology Laser System | |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and<br>in dermatology (21 CFR 878.4810, Product Code GEX) | |
| Predicate Devices: | GentleMAX Family of Laser Systems (K133283) | |

## Intended Use / Indications for Use:

The GentleLASE Family of Laser Systems is indicated for the following:

The GentleLASE Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

## GentleLASE Family of Laser Systems

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# Description:

The Candela GentleLASE Family of Laser Systems contains an alexandrite laser head, which produces laser energy emitted at nominal wavelength of 755 nm. The output of the energy is then delivered to the skin through an optical fiber delivery system which also cools the surface of the skin through either air or cryogen cooling. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen. The GentleLase Pro and GentleLase Pro LE laser systems both have the same technological and performance specifications, the same indications for use, the same principles of operation, and the same energy type. The only difference between these two systems is the color of the side panels.

| Product | Modified GentleLASE Family of<br>Laser Systems (GentleLase Pro<br>and GentleLase Pro LE Laser<br>Systems) | GentleMAX Family of Laser<br>Systems |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | KXXXXXXX | K133283 |
| Manufacturer | Candela Corporation | Candela Corporation |
| Product Code | GEX | GEX |
| Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Device Class | II | II |
| Indications for<br>Use | The GentleLASE Family of Laser<br>Systems is indicated for temporary<br>hair reduction. Stable long-term or<br>permanent reduction through<br>selective targeting of melanin in hair<br>follicles. Permanent hair reduction<br>is defined as long-term stable<br>reduction in the number of hairs<br>regrowing after a treatment regime.<br>On all skin types (Fitzpatrick I- VI)<br>including tanned skin. Permanent<br>hair reduction is defined as the long-<br>term, stable reduction in the number<br>of hairs regrowing when measured at<br>6, 9, and 12 months after the<br>completion of a treatment regime.<br>Treatment of benign pigmented<br>lesions.<br>Treatment of wrinkles.<br>The photocoagulation of | 755nm<br>The GentleMAX Family of Laser<br>Systems is indicated for temporary<br>hair reduction. Stable long-term or<br>permanent reduction through<br>selective targeting of melanin in hair<br>follicles. Permanent hair reduction<br>is defined as long-term stable<br>reduction in the number of hairs<br>regrowing after a treatment regime.<br>On all skin types (Fitzpatrick I- VI)<br>including tanned skin. Permanent<br>hair reduction is defined as the long-<br>term, stable reduction in the number<br>of hairs regrowing when measured at<br>6, 9, and 12 months after the<br>completion of a treatment regime.<br>Treatment of benign pigmented<br>lesions.<br>Treatment of wrinkles.<br>The photocoagulation of |
| Product | Modified GentleLASE Family of | GentleMAX Family of Laser |
| | Laser Systems (GentleLase Pro | Systems |
| | and GentleLase Pro LE Laser | |
| | Systems) | |
| | dermatological vascular lesions | dermatological vascular lesions |
| | (such as port-wine stains, | (such as port-wine stains, |
| | hemangiomas, telangiectasias). | hemangiomas, telangiectasias. |
| | | |
| | | 1064nm |
| | | The GentleMAX Family of Laser |
| | | Systems is indicated for the removal |
| | | of unwanted hair, for stable long |
| | | term or permanent hair reduction |
| | | and for treatment of PFB. |
| | | Permanent hair reduction is defined |
| | | as the long-term, stable reduction in |
| | | the number of hairs regrowing when |
| | | measured at 6, 9, and 12 months |
| | | after the completion of a treatment |
| | | regime. The lasers are indicated on |
| | | all skin types Fitzpatrick I-VI |
| | | including tanned skin. |
| | | Photocoagulation and hemostasis of |
| | | pigmented and vascular lesions such |
| | | as but not limited to port wine stains, |
| | | hemangioma, warts, telangiectasia, |
| | | rosacea, venus lake, leg veins and |
| | | spider veins. Coagulation and |
| | | hemostasis of soft tissue. Benign |
| | | pigmented lesions such as, but not |
| | | limited to, lentigos (age spots), solar |
| | | lentigos (sun spots), café au lait |
| | | macules, seborrheic keratosis, nevi, |
| | | chloasma, verrucae, skin tags, |
| | | keratosis, tattoos (significant |
| | | reduction in the intensity of black |
| | | and/or blue-black tattoos) and |
| | | plaques.<br>The laser is indicated for pigmented |
| | | lesions to reduce lesion size, for |
| | | patients with lesions that would |
| |…