(29 days)
Not Found
No
The document describes a laser system for dermatological treatments and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is intended for the treatment of various medical conditions such as pigmented and vascular lesions, wrinkles, scars, and onychomycosis, delivering a "controlled amount of therapeutic heat" to deep skin tissue, which aligns with the definition of a therapeutic device.
No
The device description and intended use indicate that it is a therapeutic device for skin and hair treatments, not for diagnosing medical conditions.
No
The device description clearly states it contains two separate laser heads and a delivery system, indicating it is a hardware device that produces laser light. The software verification and validation mentioned are likely for controlling the hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly indicate that this device is a laser system used for various dermatological and cosmetic procedures performed directly on the patient's body. These procedures involve applying laser energy to the skin for purposes like hair reduction, treatment of pigmented and vascular lesions, and wrinkle reduction.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient.
Therefore, this device falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
755mm:
Temporary hair reduction. Stable long-term or permanent reduction 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).
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 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 keratosis, nevi, chloasma, verucae, 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.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
Product codes
GEX
Device Description
The GentleMax Pro Plus 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The following performance data supports the substantial equivalence determination:
Electrical Safety and Electromagnetic Compatibility Standards
- IEC 60825-1: Safety of Laser Products – Part 1: Equipment classification and requirements
- IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for safety - collateral standard: electromagnetic compatibility (EMC)requirements and test
- . IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- . IEC 60601-2-22: Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Biocompatibility
The biocompatibility of the GentleMax Pro Plus has been established based on the predicate devices and the results of ISO 10993-5 and ISO 10993-10 series of testing.
Software Verification & Validation
Software verification and validation testing was conducted and results demonstrated that testing results were found acceptable for software release. Software testing was performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
Clinical Testing
Based on the similarities of the device specifications, intended use, indications for use between the GentleMax Pro Plus and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
May 26, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Candela Corporation Yverre Bobay Director, Regulatory Affairs 251 Locke Dr Marlborough, Massachusetts 01752
Re: K201111
Trade/Device Name: GentleMax Pro Plus 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: April 24, 2020 Received: April 27, 2020
Dear Yverre Bobay:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K201111
Device Name GentleMAX Family of Laser Systems
Indications for Use (Describe)
755mm:
Temporary hair reduction. Stable long-term or permanent reduction 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).
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 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 keratosis, nevi, chloasma, verucae, 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.
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary GentleMax Pro Plus System
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92
1. DATE PREPARED
April 24, 2020
2. APPLICANT NAME
Yverre Bobay Global Director, Regulatory Candela Corporation 251 Locke Drive Marlborough MA 01752 M: (617) 669-6181 yverreb@candelamedical.com
3. Official Correspondent
Greg Wallender VP, Global Quality & Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, MA 01778 M: (925) 206-5439 gregw@candelamedical.com
4. DEVICE INFORMATION
| Proprietary Name: | GentleMax Family of Laser Systems |
|---|---|
| Common/Usual Name: | Dermatology Laser System |
| Classification Name: | Laser surgical instrument for use in General and Plastic |
| surgery and in dermatology (21 CFR Section 878.4810, | |
| Product Code GEX) | |
| Product Code: | GEX |
| Device Classification: | Class II |
| Laser Classification: | Class IV |
5. PREDICATE DEVICE
Candela GentleMAX Family of Lasers System (K140122).
5
6. INTENDED USE/INDICATION FOR USE
There are no new Intended Uses for the GentleMax Pro Plus. The Indications for Use Statement is unchanged for the GentleMax Pro Plus is as follows:
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.
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), cafe 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.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
6
7. DEVICE DESCRIPTION
The GentleMax Pro Plus 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.
8. TECHNOLOGICAL CHARACTERISTICS
The new GentleMax Pro Plus system has the same design, technological characteristics, operating principles, and intended use as the Candela GentleMax Family of Laser System (K140122). The devices share the same technical features, such as calibration port, wavelengths, laser medium, delivery systems, power supply, cooling system, electronics, firmware and user display screen. The devices share the same operating principles, such as energy but the Gentle Max Pro Plus offers a faster repetition rate, and offers larger spot sizes. Any minor differences do not raise any new types of safety or effectiveness questions because the GentleMax Pro Plus parameters are similar to the predicates.
| Specifications | Modified Candela
GentleMax Pro Plus | Current Candela
GentleMax Pro |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Candela Corp. | Candela Corp. |
| K Number | Not Assigned | K140122 |
| Product Code | GEX | GEX |
| Regulation
Number | 878.4810 | 878.4810 |
| Device Class | II | II |
| Indications
for Use | The GentleMax Family of Laser Systems is
indicated for the following at the specified
wavelength:
755 nm
Temporary hair reduction. Stable long-term
or permanent reduction through selective
targeting of melanin in hair follicles.
Permanent hair reduction is defined as long- | The GentleMax Family of Laser Systems is
indicated for the following at the specified
wavelength:
755 nm
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). | 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 1-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 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. | 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 1-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 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.) | 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.) |
| Laser Type | Flashlamp-excited, Solid state Alexandrite and Nd:YAG laser | Flashlamp-excited, Solid state Alexandrite and Nd:YAG laser |
| Aiming Beam | Green diode laser
(520-550 nm) | Green diode laser
(520-550 nm) |
| Wavelengths
(nm) | 755 & 1064 | 755 & 1064 |
| Maximum | 68 Joules (J) ALEX; 90 J | 53 joules (J) ALEX; 80 J |
| Energy (J) | Nd:YAG | Nd: YAG |
| Accuracy of
Output | ± 20% | ± 20% |
| Maximum
Fluence
(J/cm2) | 400 J/cm2 (ALEX)
520 J/cm2 (YAG) | 400 J/cm2 (ALEX)
520 J/cm2 (YAG) |
| Spot Size
(mm) | 1.5 mm, 3 mm, 3x10 mm, 5 mm,
6 mm, 8 mm, 10 mm, 12 mm, 15
mm, 18 mm, 20 mm, 22 mm, 24
mm, 26 mm | 1.5 mm, 3 mm, 3x10 mm, 5 mm,
6 mm, 8 mm, 10 mm, 12 mm, 15
mm, 18 mm |
| Repetition
Rate (Hz) | 1 – 10 Hz | 1 - 10 Hz |
| Pulse
Duration (ms) | 0.25 - 100 ms (new 2ms) | 0.25 - 100 ms |
| Operating
Modes | Pulse | Pulse |
| Energy
Delivery | Footswitch & finger switch | Footswitch & Handpiece switch |
| Beam
Delivery | Lens-coupled optical fiber | Lens-coupled optical fiber |
| Voltage and
Power (30A
configuration) | 200 V to 240 V~, 50/60 Hz,
single phase, 4,600 VA or 20 A at
230 V~ | 200 V to 240 V~, 50/60 Hz,
single phase, 4,600 VA or 20 A at
230 V~ |
| Voltage and
Power (20A
configuration) | 200 V to 240 V~, 50/60 Hz,
single phase, 3,600 VA or 16 A at
230 V~ | 200 V to 240 V~, 50/60 Hz,
single phase, 3,600 VA or 16 A at
230 V~ |
| System
Cooling | Ambient Air | Ambient Air |
| Skin Cooling | Yes
Cryogen (DCD) | Yes
Cryogen (DCD) |
| Software/GUI/
Touch Screen | Yes | Yes |
| Dimension in
Inches
(H x W x L) | 42 x 18 x 27 | 42 x 18 x 27 |
| Weight
(Pounds) | 260 | 260 |
| Power Supply | Yes | Yes |
Comparison Table of Technological Characteristics
7
8
9
9. PERFORMANCE DATA
The following performance data supports the substantial equivalence determination:
Electrical Safety and Electromagnetic Compatibility Standards
- IEC 60825-1: Safety of Laser Products – Part 1: Equipment classification and requirements
- IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for safety - collateral standard: electromagnetic compatibility (EMC)requirements and test
- . IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- . IEC 60601-2-22: Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Biocompatibility
The biocompatibility of the GentleMax Pro Plus has been established based on the predicate devices and the results of ISO 10993-5 and ISO 10993-10 series of testing.
Software Verification & Validation
Software verification and validation testing was conducted and results demonstrated that testing results were found acceptable for software release. Software testing was performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
Clinical Testing
Based on the similarities of the device specifications, intended use, indications for use between the GentleMax Pro Plus and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification.
10. STATEMENT OF SAFETY AND EFFECTIVENESS
The GentleMax Pro Plus and shares a similar design and intended use to its predicate (K140122). Additionally, technological characteristics, including wavelengths, laser mediums, pulse width, spot sizes, energy, cooling systems, and repetition rate are similar between the GentleMax Pro Plus and its predicate devices. The modifications to the device do not raise new types of questions regarding safety and efficacy, and the data presented in this 510(k) Premarket Notification supports that the device is substantially equivalent to the predicate device.