(55 days)
Not Found
No
The provided text describes a laser device for various dermatological and aesthetic procedures. There is no mention of AI or ML in the intended use, device description, or performance studies summary. The technology described is based on established laser principles.
Yes
The device is intended for various medical treatments, including the treatment of benign pigmented and vascular lesions, wrinkles, acne, relief of muscle and joint pain and stiffness, and treatment of onychomycosis, all of which are considered therapeutic applications.
No
This device is a therapeutic laser system used for various dermatological and aesthetic treatments, not for diagnosing conditions. Its indications include hair reduction, treatment of skin lesions, wrinkles, acne, and pain relief.
No
The device description clearly states it is based on Nd:YAG and Alexandrite laser technology and includes a physical console, laser unit, optical fiber delivery system, and handpiece/scanner. These are hardware components, not software.
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 AvalancheLase Family is a laser system used for various dermatological and aesthetic treatments directly on the patient's body (hair reduction, lesion treatment, wrinkle treatment, etc.). It does not analyze samples taken from the body.
- Intended Use: The stated intended uses are all therapeutic or aesthetic procedures performed externally on the patient.
- Device Description: The description details a laser unit and delivery system, not equipment for analyzing biological samples.
Therefore, the AvalancheLase Family falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AvalancheLase Family and its accessories will be marketed for the following indications for use:
Alexandrite laser (755 nm wavelength): Indications in Dermatology and Aesthetics
- · Temporary hair reduction.
- · Stable long-term or permanent hair 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 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 benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG laser (1064 nm wavelength):
The Nd:YAG laser module is intended for incision, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.
Indications in Dermatology and Aesthetics:
- · Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned thair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6.9 and 12 months after the completion of a treament regime.
- · Treatment of wrinkles.
- · Treatment of wrinkles with S11 (LX Runner) scanner.
- · Treatment of mild to moderate inflammatory acne vulgaris.
- · Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains,
- hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
- · Podiatry (ablation, vaporization, incision, and coagulation of soft tissue) including:
- Matrixectomy
- Radical nail excision
- Periungual and subungual warts
- Plantar warts
- Neuromas
- · Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
NNd:YAG laser (1064 nm wavelength) therapy:
- Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.
Product codes
GEX
Device Description
The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamppumped laser sources in one housing, with optical cavities containing the Nd:YAG and Alexandrite crystals. A green diode aiming beam (520 mm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical manual handpiece or scanner.
The AvalancheLase Family is designed to operate in single wavelength (Nd:YAG or Alexandrite) configurations (models) and dual wavelength (Nd: YAG and Alexandrite) configurations (models).
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-Clinical Summary:
The AvalancheLase Family has been evaluated via verification and validation tests and inspections for conformance to the applicable regulations and safety standards. The AvalancheLase Family is designed, tested and will be manufactured in accordance with both, mandatory and voluntary standards:
AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
IEC 60601-2-22:2007 + A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60601-1-6:2010 + A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
IEC 60601-1-9:2007 + A1:2013 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral standard: Requirements for environmentally conscious design.
IEC 60825-1:2014 Safety of laser products. Part 1: Equipment classification and requirements.
IEC 62366:2007 + A1:2014 Medical devices - Application of usability engineering to medical devices.
IEC 62366-2015 Medical devices - Part 1: Application of usability engineering to medical device
IEC 62304:2006 + A1:2015 Medical device Software - software life-cycle process.
ISO standards:
ISO 14971:2019 Medical devices - Application of risk management to medical devices
ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
ISO 10993-1:2018 (state-of-the-art edition)* Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Software verification/validation
AvalancheLase Family is a laser device controlled by software. Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator.
Biocompatibility
Biological evaluation according to ISO 10993-1 and the FDA guidance recommendations was performed on handpieces and scanner, which are the only parts that come in direct contact with the patient. Based on nature of body contact and the duration (time) of contact the following endpoints were considered: Physical and/or Chemical Information, Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Material Mediated Pyrogenicity and Acute Systemic Toxicity.
Clinical Summary:
No premarket clinical investigations for AvalancheLase Family were conducted since the performance of the device under evaluation is based on well-established laser technology with long history of use for the same intended purpose and it is additionally sufficiently supported by clinical trials assessing performance and safety published in peer reviewed scientific journals.
Conclusions:
The AvalancheLase Family indications for use and technological characteristics do not raise new types of questions regarding safety and efficacy when compared to the predicates. Based on its technical characteristics, design, functional features, performance test data, and its indications for use as listed above, the AvalancheLase Family is considered to be as safe, as effective and to perform as well as the predicate devices.
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.
Dynamis Pro Family (K213267), Family of CoolGlide Aesthetic Lasers (K153671), GentleMAX Family of Laser Systems (K201111), GentleLASE Family of Laser Systems (K140732), DEKA MOTUS AX (K162886)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 19, 2023
Fotona d.o.o. Tina Bartolic Ouality Assurance and Regulatory Affaris Stegne 7 Ljubljana, 1000 Slovenia
Re: K223540
Trade/Device Name: AvalancheLase Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: November 24, 2022 Received: November 25, 2022
Dear Tina Bartolic:
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
1
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 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 (QS) 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 medical devices and radiation-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,
Image /page/1/Picture/5 description: The image shows the text "Jianting Wang -S" in a large, clear font. The text is horizontally oriented and appears to be the primary focus of the image. The background is plain and does not distract from the text.
Jianting Wang 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
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Indications for Use
510(k) Number (if known) K223540
Device Name AvalancheLase Family
Indications for Use (Describe)
The AvalancheLase Family and its accessories will be marketed for the following indications for use:
Alexandrite laser (755 nm wavelength): Indications in Dermatology and Aesthetics
-
· Temporary hair reduction.
· Stable long-term or permanent hair 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 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 benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG laser (1064 nm wavelength):
The Nd:YAG laser module is intended for incision, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.
Indications in Dermatology and Aesthetics:
· Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned thair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6.9 and 12 months after the completion of a treament regime.
· Treatment of wrinkles.
- · Treatment of wrinkles with S11 (LX Runner) scanner.
- · Treatment of mild to moderate inflammatory acne vulgaris.
· Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains,
-
hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
· Podiatry (ablation, vaporization, incision, and coagulation of soft tissue) including: -
Matrixectomy
-
Radical nail excision
-
Periungual and subungual warts
-
Plantar warts
-
Neuromas
· Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
NNd:YAG laser (1064 nm wavelength) therapy:
3
| • Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood |
|---|
| circulation and/or promoting relaxation of muscle. |
| 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)
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510k Summary
SUBMITTER'S INFORMATION
Submitter:
Fotona d.o.o. Stegne 7 1000 Ljubljana, Slovenia Phone: +386 1 5009 100 Fax: + 386 1 5009 200
Contact Person:
Tina Bartolic, Quality Assurance and Regulatory Affairs Phone: + 386 1 5009 100 E-mail: tina.bartolic@fotona.com
Date:
January 6, 2023
DEVICE INFORMATION
| Device Trade Name: | AvalancheLase Family |
|---|---|
| Common name: | Medical Laser System |
| Classification name: | Laser Surgical Instrument For Use In General And Plastic Surgery |
| And In Dermatology (21 CFR 878.4810; Class II) | |
| Product Code: | GEX |
PREDICATE DEVICES
Dynamis Pro Family (K213267) Family of CoolGlide Aesthetic Lasers (K153671) GentleMAX Family of Laser Systems (K201111) GentleLASE Family of Laser Systems (K140732) DEKA MOTUS AX (K162886)
DEVICE DESCRIPTION SUMMARY
The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamppumped laser sources in one housing, with optical cavities containing the Nd:YAG and Alexandrite crystals. A green diode aiming beam (520 mm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical manual handpiece or scanner.
5
The AvalancheLase Family is designed to operate in single wavelength (Nd:YAG or Alexandrite) configurations (models) and dual wavelength (Nd: YAG and Alexandrite) configurations (models).
INTENDED USE/INDICATIONS FOR USE
The AvalancheLase Family and its accessories will be marketed for the following indications for use:
Alexandrite laser (755 nm wavelength):
Indications in Dermatology and Aesthetics
- · Temporary hair reduction.
- · Stable long-term or permanent hair 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 longterm, 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 benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG laser (1064 nm wavelength):
The Nd:YAG laser module is intended for incision, ablation, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.
Indications in Dermatology and Aesthetics
- · Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
- · Treatment of wrinkles.
- · Treatment of wrinkles with S11 (LX Runner) scanner.
- · Treatment of mild to moderate inflammatory acne vulgaris.
- · Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins;
- · Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy
- Radical nail excision
6
- Periungual and subungual warts
- Plantar warts
- Neuromas
- · Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
Nd:YAG laser (1064 nm wavelength) therapy:
- · Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.
INDICATIONS FOR USE COMPARISON
The indications for use from the predicate devices that are included in the AvalancheLase Family do not raise new types of questions regarding safety and effectiveness. The indications with the Nd:YAG (1064 nm) and Alexandrite (755 nm) laser output are based on previously cleared indications of predicate devices.
TECHNOLOGICAL COMPARISON
A comparison of the technical specifications for the intended use of the AvalancheLase Family with the previously cleared device is provided in Table 1.
Table 1: The comparison of technical capabilities and characteristics between Dynamis Pro Family (K213267), Family of CoolGlide Aesthetic Lasers (K153671), GentleMAX Family of Laser Systems (K201111), GentleLASE Family of Laser Systems (K140732) and DEKA MOTUS AX (K162886) and AvalancheLase Family (this submission) for the Alexandrite and Nd:YAG laser wavelengths
| | Fotona
Dynamis
Pro
Family
(K213267) | Cutera
Family of
CoolGlide
Aesthetic
Lasers
(K153671) | Candela
GentleMAX
Family of
Laser
Systems
(K201111) | Candela
GentleLASE
Family of
Laser
Systems
(K140732) | DEKA
MOTUS
AX
(K162886) | Fotona AvalancheLase
Family
(this submission) | |
|----------------|-------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------|----------------------------------------|
| | Nd:YAG | Alexandrite | Alexandrite | Alexandrite | Alexandrite | Alexandrite | Nd:YAG |
| Wavelength | 1064 nm | 755 nm | 755 nm | 755 nm | 755 nm | 755 nm | 1064 nm |
| Laser
media | Flashlamp
solid state
Nd:YAG rod | Flashlamp
solid state
Alexandrite
rod | Flashlamp solid
state
Alexandrite rod | Flashlamp solid
state Alexandrite
rod | Flashlamp
solid state
Alexandrite
rod | Flashlamp
solid state
Alexandrite
rod | Flashlamp
solid state
Nd:YAG rod |
| Aiming
beam | 650 nm | 635 nm | 520-550 nm | 520-550 nm | 532 nm | 520 nm | 520 nm |
| Output
mode | Pulsed | Pulsed | Pulsed | Pulsed | Pulsed | Pulsed | Pulsed |
| Fluence | Up to 600
J/cm² | Up to 100
J/cm² | Up to 400 J/cm² | 53 J/cm² | Up to 600
J/cm² | Up to 500
J/cm² | Up to 600
J/cm² |
| Spotsize | 2-20 mm | 5 - 18 mm | 1.5 -26 mm | 6-24 mm | 2.5-20 mm | 2-30 mm | 2-30 mm |
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| Pulse width | 0.1 - 50 ms | 3 ms | 0.25-100 ms | 3-300 ms | 0.25-300 ms | 0.2 – 200 ms | 0.1 - 200 ms |
|---|---|---|---|---|---|---|---|
| Repetition | |||||||
| rate | Up to 100 Hz |