CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
Device Facts
| Record ID | K140122 |
|---|---|
| Device Name | CANDELA GENTLEMAX FAMILY OF LASER SYSTEM |
| Applicant | Candela Corp. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | May 9, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The GentleMAX Family of Laser Systems is indicated for the following at the specified wavelength: 755nm 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. 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. On all skin types (Fitzpatrick I- VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). 1064nm 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. The laser is 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. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. 1064nm Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
Device Story
GentleMAX Family of Laser Systems (GentleMax Pro) utilizes dual laser heads (Alexandrite 755nm and Nd:YAG 1064nm) to deliver therapeutic heat to skin tissue. System optically combines beams onto a single delivery rail and fiber-optic handpiece. Dynamic Cooling Device (DCD) sprays cryogen onto skin surface prior to laser pulse to protect upper layers. Operated by clinicians in dermatology/surgical settings via fingerswitch or footswitch. Output controlled via LCD color touchscreen. Laser energy targets melanin, vascular structures, or soft tissue for coagulation/hemostasis. Clinical benefit includes hair reduction, lesion removal, and nail clarity improvement.
Clinical Evidence
Bench testing only. Testing performed to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-22 standards. Performance specifications verified to be identical to predicate devices.
Technological Characteristics
Flashlamp-pumped solid-state rod laser; 755nm (Alexandrite) and 1064nm (Nd:YAG) wavelengths. Optical fiber delivery system with handpiece; spot sizes 1.5-18mm. Dynamic Cooling Device (DCD) cryogen spray. LCD color touchscreen interface. Fingerswitch/footswitch activation. Pulse duration 0.25-100ms; repetition rate up to 10Hz.
Indications for Use
Indicated for patients requiring hair reduction, treatment of benign pigmented/vascular lesions, wrinkle treatment, scar reduction, or temporary increase of clear nail in onychomycosis. Applicable to all Fitzpatrick skin types (I-VI) including tanned skin.
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
Submission Summary (Full Text)
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# 510(k) Summary GentleMAX Family of Laser Systems
## General Information:
This Traditional 510(k) is to provide notification of substantial equivalence for the GentleMAX Family of Laser Systems (GentleMax Pro Laser System) to the cleared Cutera GenesisPlus Laser (K122493) manufactured by Cutera, Inc. and the cleared GentleMAX Family of Laser Systems (K133283).
| Submitted by: | Candela Corporation<br>530 Boston Post Road<br>Wayland, MA 01778-1886 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sam Wade,<br>Global Vice President, Regulatory Affairs<br>Tel: 508-358-7400 x330<br>Fax: 508-358-5602 |
| Date prepared: | January 13, 2014 |
| Trade Name: | GentleMAX 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)<br>Cutera GenesisPlus Laser System (K122493) |
## Intended Use / Indications for Use:
The GentleMAX Family of Laser Systems is indicated for the following at the specified wavelength:
## 755mm
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. 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. On all skin types (Fitzpatrick I- VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
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The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
## 1064nm
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.
The laser is 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.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
#### 1064nm
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
#### Description:
The Candela GentleMAX Family of Laser Systems contains two separate laser heads (Alexandrite and Nd: YAG), which produce laser light outputs of 755 nm and 1064 nm. respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. 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.
## Technological Characteristics:
The Candela GentleMAX Family of Laser Systems delivers laser energy through an optical fiber handpiece delivery system, which can output either 755 nm or 1064 nm wavelengths. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch (fingerswitch or footswitch) is used to control the delivery of laser pulses. The Dynamic Cooling Device provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of
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1.5, 3, 6, 8, 10, 12, 15 and 18 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece.
| Summary of Technological Characteristics<br>Product | Modified GentleMAX Family of<br>Laser Systems (GentleMax Pro Laser System) | Cutera GenesisPlus Laser System |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K140122 | K122493 |
| Manufacturer | Candela Corporation | Cutera, Inc. |
| Product Code | GEX | PDZ, GEX |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Device Class | II | II |
| Indications for Use | The GentleMAX Family of Laser Systems is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.). | The Cutera GenesisPlus laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.). |
| Laser Media | Flashlamp pumped solid state rod | Flashlamp pumped solid state rod |
| Wavelength | 1064nm Nd:YAG | 1064nm Nd:YAG |
| Pulse duration | 0.3ms | 0.3ms |
| Fluence | 15-18 J/cm2 | 15-18 J/cm2 |
| Spot size | 5mm | 5mm |
| Repetition rate | 2-3 Hz | 2-3 Hz |
| Laser activation | Fingerswitch or footswitch | Footswitch |
| Output mode | Pulsed | Pulsed |
| User Interface | LCD color touchscreen | LCD color touchscreen |
| Summary of Technological Characteristics | |
|------------------------------------------|--|
| Product | Modified GentleMAX Family of<br>Laser Systems (GentleMax Pro<br>Laser System) | GentleMAX Family of Laser<br>Systems (GentleMax Pro Laser<br>System) |
|---------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 510(k) | K140122 | K133283 |
| Manufacturer | Candela Corporation | Candela Corporation |
| Product Code | GEX | GEX |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Device Class | II | II |
| Indications for Use | 755nm | 755nm |
| | The GentleMAX Family of Laser<br>Systems is indicated for | The GentleMAX Family of Laser<br>Systems is indicated for |
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temporary hair reduction. Stable temporary hair reduction. Stable long-term or permanent reduction long-term or permanent reduction through selective targeting of through selective targeting of melanin in hair follicles. melanin in hair follicles. Permanent hair reduction is Permanent hair reduction is defined as long-term stable defined as long-term stable reduction in the number of hairs reduction in the number of hairs regrowing after a treatment regrowing after a treatment regime. On all skin types regime. On all skin types (Fitzpatrick I- VI) including (Fitzpatrick I- VI) including tanned skin. Permanent hair tanned skin. Permanent hair reduction is defined as the longreduction is defined as the longterm, stable reduction in the term, stable reduction in the number of hairs regrowing when number of hairs regrowing when measured at 6, 9, and 12 months measured at 6, 9, and 12 months after the completion of a after the completion of a treatment regime. treatment regime. Treatment of benign pigmented Treatment of benign pigmented lesions. lesions. Treatment of wrinkles. Treatment of wrinkles. The photocoagulation of The photocoagulation of dermatological vascular lesions dermatological vascular lesions (such as port-wine stains, (such as port-wine stains, hemangiomas, telangiectasias). hemangiomas, telangiectasias). 1064nm 1064nm The GentleMAX Family of Laser The GentleMAX Family of Laser Systems is indicated for the Systems is indicated for the removal of unwanted hair, for removal of unwanted hair, for stable long term or permanent stable long term or permanent hair reduction and for treatment hair reduction and for treatment of PFB. Permanent hair reduction of PFB. Permanent hair reduction is defined as the long-term, stable is defined as the long-term, stable reduction in the number of hairs reduction in the number of hairs regrowing when measured at 6, 9, regrowing when measured at 6, 9. and 12 months after the and 12 months after the completion of a treatment regime. completion of a treatment regime. The lasers are indicated on all The lasers are indicated on all skin types Fitzpatrick I-VI skin types Fitzpatrick I-VI including tanned skin. including tanned skin. Photocoagulation and hemostasis Photocoagulation and hemostasis of pigmented and vascular lesions of pigmented and vascular lesions such as but not limited to port such as but not limited to port wine stains, hemangioma, warts, wine stains, hemangioma, warts, telangiectasia, rosacea, venus telangiectasia, rosacea, venus lake, leg veins and spider veins. lake, leg veins and spider veins.
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| | Coagulation and hemostasis of | Coagulation and hemostasis of |
|-----------------------|--------------------------------------|--------------------------------------|
| | | |
| | soft tissue. Benign pigmented | soft tissue. Benign pigmented |
| | lesions such as, but not limited to, | lesions such as, but not limited to, |
| | lentigos (age spots), solar lentigos | lentigos (age spots), solar lentigos |
| | (sun spots), café au lait macules, | (sun spots), café au lait macules, |
| | seborrheic keratosis, nevi, | seborrheic keratosis, nevi, |
| | chloasma, verrucae, skin tags. | chloasma, verrucae, skin tags, |
| | keratosis, tattoos (significant | keratosis, tattoos (significant |
| | reduction in the intensity of black | reduction in the intensity of black |
| | and/or blue-black tattoos) and | and/or blue-black tattoos) and |
| | plaques. | plaques. |
| | The laser is indicated for | The laser is indicated for |
| | pigmented lesions to reduce | pigmented lesions to reduce |
| | lesion size, for patients with | lesion size, for patients with |
| | lesions that would potentially | lesions that would potentially |
| | benefit from aggressive treatment, | benefit from aggressive treatment, |
| | and for patients with lesions that | and for patients with lesions that |
| | have not responded to other laser | have not responded to other laser |
| | treatments. | treatments. |
| | The laser is also indicated for the | The laser is also indicated for the |
| | reduction of red pigmentation in | reduction of red pigmentation in |
| | hypertrophic and keloid scars | hypertrophic and keloid scars |
| | where vascularity is an integral | where vascularity is an integral |
| | part of the scar. | part of the scar. |
| | Treatment of wrinkles. | Treatment of wrinkles. |
| Laser type | Flashlamp-excited, Solid state | Flashlamp-excited, Solid state |
| | Alexandrite and Nd: Y AG laser | Alexandrite and Nd: Y AG laser |
| Wavelength | 755nm/1064nm | 755nm/1064nm |
| Pulse duration | 0.25 - 100 ms | 0.25 - 100 ms |
| Maximum fluence | 53 J/cm2 (ALEX) | 53 J/cm2 (ALEX) |
| | 80 J/cm2 (YAG) | 80 J/cm2 (YAG) |
| Spot size | 1.5, 3, 6, 8, 10, 12, 15, 18mm | 1.5, 3, 6, 8, 10, 12, 15, 18mm |
| Pulse repetition rate | 10 Hz, maximum | 10 Hz, maximum |
| Pulsing control | Fingerswitch or footswitch | Fingerswitch or footswitch |
| Product dimensions | 42" x 18" x 27" | 42" x 18" x 27" |
| (HxWxL) | | |
| Product Weight | 260 lbs | 260 Ibs |
·
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#### Performance Data:
Testing to the third edition of IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-22 has been conducted on the GentleMax Pro Laser System. Bench testing has also been performed to show that the performance specifications of our product are identical to the predicate device. All performance testing demonstrated that the GentleMax Pro Laser System performs according to specifications and functions as intended.
### Clinical Data:
No clinical data was required.
#### Summary of Substantial Equivalence:
The GentleMAX Family of Laser Systems have the same intended uses, utilize similar operating principles, and match key design aspects, including similar spot size, the same wavelengths and the variable delivered fluence, in comparison to the predicate devices. The addition of a new indication to the GentleMAX Family of Laser Systems raises no new issues of safety or effectiveness. On the basis of similarities in method of operation, intended uses, and key technical characteristics, Candela Corporation believes that the GentleMAX Family of Laser Systems is substantially equivalent to the predicate devices.
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#### 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
May 9, 2014
Candela Corporation Mr. Sam Wade Global Vice President, Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01788
Re: K140122
Trade/Device Name: GentleMAX 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, PDZ Dated: April 28. 2014 Received: April 29, 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 warrantics. 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 complics 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Sam Wade
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 (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours, Binita S. Ashar -S 2014.05.09 15:13:43 -04'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting 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)
#### K140122
Device Name GentleMAX Family of Laser Systems
Indications for Use (Describe)
The GentleMAX Family of Laser Systems is indicated for the specified wavelength:
#### 755mm
Temporary hair reduction. Stable long-term or permanent reductive 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. 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. On all skin types (Fitzpatrick I-VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectas)
#### 1064nm
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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. 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, sebortheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is 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.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
#### 1064nm
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and /or yeast Candida Albicans, etc.)
Type of Use (Select one or both, as applicable)
8 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (1/14)
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PSC Publishing Services (301) 443-6746 EF
GentleMAX Family of Laser Systems
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# FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Neil R Ogden -S For BSA 2014.05.08 09:15:37 -04'00' This section applies only to requirements of the Paperwork Reduction Act of 1995.
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