(16 days)
Not Found
No
The description focuses on the hardware components, laser technology, and a microprocessor-based system controller for parameter selection and monitoring. There is no mention of AI, ML, or image processing for analysis or decision-making.
Yes
The device is indicated for treatment of various medical conditions such as benign pigmented lesions, dermatological vascular lesions, and reduction of red pigmentation in hypertrophic and keloid scars, which are therapeutic applications. Additionally, the device's technical standard conformity includes "IEC 60601-2-22 Medical Electrical Equipment- Safety of Diagnostic and Therapeutic Laser Equip.", explicitly stating it is a therapeutic laser equipment.
No
The device is a laser system indicated for therapeutic procedures such as hair reduction, treatment of benign pigmented lesions, wrinkles, and vascular lesions. It does not perform any diagnostic functions.
No
The device description clearly outlines multiple hardware components including laser heads, power supply, optical delivery system, and a dynamic cooling device. While it mentions a "Software control system," this is listed as one of six major components, indicating it's part of a larger hardware system, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The GentleMAX Family of Laser Systems is a therapeutic device that uses laser energy to directly treat conditions on the skin (hair reduction, pigmented lesions, vascular lesions, wrinkles). It does not analyze samples taken from the body.
- Intended Use: The intended uses clearly describe direct treatment of the skin, not analysis of biological samples.
- Device Description: The description details the laser technology, delivery system, and cooling mechanism, all of which are consistent with a therapeutic laser device. There is no mention of components or processes related to analyzing biological specimens.
Therefore, the GentleMAX Family of Laser Systems falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
755mm
The GentleMAX 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.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, 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. 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), cafe 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.
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.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Candela GentleMAX Family of Lasers 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.
Each laser head contains the appropriate solid state laser rod and high intensity xenon flashlamps to excite the laser medium. The laser heads are water cooled with a self contained circulating water system that includes a water to air heat exchanger so the system can be fully air-cooled. The temperature of the laser heads are regulated by the circulation of distilled water at a controlled temperature.
A high voltage power supply is used to charge a storage capacitor which provides energy to the flashlamps. An IGBT (high voltage switch) is used to discharge the capacitor through the flashlamp. Each laser head has its own dedicated IGBT switch which is how the system controls which wavelength is produced. The resulting flash of the flashlamp excites the laser rod which causes emission of a pulse of laser energy.
The Candela GentleMAX Laser System delivers laser energy with various pulse durations from 0.25 milliseconds to 300 milliseconds. The output of this laser is delivered to the area of reamment by means of a lens coupled user replaceable optical fiber with a treatment her and are artacted to its distal end. A trigger switch (fingerswitch or footswitch) is used to control the delivery of laser pulses. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be delivered repetitively as long as the switch is depressed, at repetition rates up to 10 pulses per second (depending on the chosen pulse duration).
Energy from the laser is directed to the target area via optical fiber handpiece delivery system. 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 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.
A microprocessor based system controller is used to monitor and direct all system functions. Operators of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via a touch screen and display panel. The touch screen panel can also be used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
The GentleMAX Family of Laser Systems are designed with six major components:
- High voltage power supply and modulator system
- Optical laser head
- Circulator system
- Optical delivery system
- Software control system
- Dynamic cooling device
The Candela GentleMAX Family of Laser Systems are equipped with safety interlock systems to protect patients and operators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
As laser products, the GentleMAX Family of Laser Systems conform to the Laser Performance Standard (21 CFR 1040). In addition, the GentleMAX Family of Laser Systems conform to IEC (EN) 60601-1 Medical Electrical Equipment- Gen'1 Requirements for Safety, IEC 60601-1-2 Medical Electrcal Equipment- Electromagnetic Compatibility, IEC 60601-1-4 Medical Electrical Equipment- Programmable Electrical Medical Systems, IEC 60825-1, and IEC 60601-2-22 Medical Electrical Equipment- Safety of Diagnostic and Therapeutic Laser Equip.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
E. GentleMAX Family of Laser Systems 510k Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela GentleMAX Family of Laser Systems using 755 nm Alexandrite laser, which is substantially equivalent to previously marketed devices intended for the photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
| Submitted by: | Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sam Wade, VP of Quality and Regulatory Affairs |
| Date prepared: | August 1, 2011 |
| Classification: | Class II GEX Product Code
(21 CFR § 878.4810 Laser Surgical Instrument for use in
General and Plastic Surgery and in Dermatology) |
| Common Name: | Dermatology Laser, GentleMAX Family of Laser Systems |
| Predicate Devices: | GentleLASE Family of Laser Systems
(K111144)
Candela 3630 Laser System
(now named Candela GentleMAX Laser System)
(K063074) |
Description:
The Candela GentleMAX Family of Lasers 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.
Each laser head contains the appropriate solid state laser rod and high intensity xenon flashlamps to excite the laser medium. The laser heads are water cooled with a self contained circulating water system that includes a water to air heat exchanger so the system can be fully air-cooled. The temperature of the laser heads are regulated by the circulation of distilled water at a controlled temperature.
A high voltage power supply is used to charge a storage capacitor which provides energy to the flashlamps. An IGBT (high voltage switch) is used to discharge the capacitor through the flashlamp. Each laser head has its own dedicated IGBT switch which is how the system controls which wavelength is produced. The resulting flash of the flashlamp excites the laser rod which causes emission of a pulse of laser energy.
The Candela GentleMAX Laser System delivers laser energy with various pulse durations from 0.25 milliseconds to 300 milliseconds. The output of this laser is delivered to the area of reamment by means of a lens coupled user replaceable optical fiber with a treatment her and are artacted to its
1
distal end. A trigger switch (fingerswitch or footswitch) is used to control the delivery of laser pulses. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be delivered repetitively as long as the switch is depressed, at repetition rates up to 10 pulses per second (depending on the chosen pulse duration).
Energy from the laser is directed to the target area via optical fiber handpiece delivery system. 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 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.
A microprocessor based system controller is used to monitor and direct all system functions. Operators of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via a touch screen and display panel. The touch screen panel can also be used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
The GentleMAX Family of Laser Systems are designed with six major components:
-
- High voltage power supply and modulator system
-
- Optical laser head
-
- Circulator system
-
- Optical delivery system
- S. Software control system
-
- Dynamic cooling device
The Candela GentleMAX Family of Laser Systems are equipped with safety interlock systems to protect patients and operators.
Testing:
As laser products, the GentleMAX Family of Laser Systems conform to the Laser Performance Standard (21 CFR 1040). In addition, the GentleMAX Family of Laser Systems conform to IEC (EN) 60601-1 Medical Electrical Equipment- Gen'1 Requirements for Safety, IEC 60601-1-2 Medical Electrcal Equipment- Electromagnetic Compatibility, IEC 60601-1-4 Medical Electrical Equipment- Programmable Electrical Medical Systems, IEC 60825-1, and IEC 60601-2-22 Medical Electrical Equipment- Safety of Diagnostic and Therapeutic Laser Equip.
Summary of Substantial Equivalence:
The Candela GentleMAX Family of Laser Systems have intended uses, utilizes similar operating principles and matches key design aspects, including similar spot size, the same wavelengths and the same maximum delivered fluence as the predicate devices. On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela Corporation believes that the Candela GentleMAX Family of Laser Systems are substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows a seal with a symbol and text around it. The symbol consists of three curved lines that resemble waves or streams. The text is arranged in a circular pattern around the symbol, but it is not clearly legible due to the image quality. The seal appears to be an official emblem or logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20995-0002
Candela Corporation % Mr. Sam Wade VP of Quality and Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778-1886
0CT - 5 2011
Re: K112715
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 H Product Code: GEX Dated: September 16, 2011 Received: September 20, 2011
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) imo either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your devine (ran be found in the Code of Federal Regulations, Title 21, Paris 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 – Mr. Sam Wade
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting freporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH s) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Alili H Millham
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K (122) 5
Device Name: GentleMAX Family of Laser Systems
Indications for Use:
755mm
Nil R.P. Ogden for nti
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number K112715
The GentleMAX Family of Laser Systems is indicated for temporary hair reduction. Stable longterm 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.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, 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. 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), cafe 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.
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.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)