(61 days)
Not Found
No.
The document does not mention AI, DNN, or ML, and describes a system for laser-based skin treatment controlled by pre-set parameters and user input, not an AI model.
Yes
The "Intended Use / Indications for Use" states that the device is "indicated for use in the treatment of acne scars, and dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures," which are all therapeutic medical conditions or procedures.
No
The device is indicated for treatment (coagulation of soft tissue, skin resurfacing, treatment of acne scars) rather than diagnosis.
No
The device description explicitly states that the AVAVA Skin Treatment System includes three (3) main physical components: a Console, a Tablet, and a Patient Interface, and describes hardware elements like a laser, power distribution, contact cooling, focusing optics, and a scanner. It is a physical laser system, not purely software.
No.
The AVAVA™ Skin Treatment System is a laser system intended for direct therapeutic treatment (skin resurfacing, coagulation of soft tissue, treatment of acne scars) on the human body, not for the in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The AVAVA™ Skin Treatment System is indicated for use in the treatment of acne scars, and dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The AVAVA™ Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.
The AVAVA™ Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
Product codes
ONG
Device Description
The AVAVA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the AVAVA.
The AVAVA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.
The AVAVA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port.
The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.
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
medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.
professional setting.
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
A prospective clinical study was conducted to show the safety and efficacy of treating acne scars with the Avava Skin Treatment System.
The study enrolled and treated 47 subjects of Fitzpatrick Skin Type I-VI. 41 subjects returned for a follow-up visit post treatment to be included in efficacy analysis, 29 of which returned for a 3-month follow-up visit per-protocol. Subjects received anywhere between 1 to 6 treatments during the study and then began the follow-up process within the protocol, which included collection of photography after the treatment series was complete. Photographs were presented to a panel of evaluators who identified a 1-point improvement in ECCA score in 90.2% of subjects. A panel of blinded evaluators correctly identified post-treatment images for 89.4% of subjects. Treating physicians also assessed subject level of improvement with a review of photography and showed 78% improvement. Treatment was well tolerated by all subjects with an average pain score of 4.4/10.
Overall, the MIRIA Laser was found to be safe and effective for the treatment of Acne Scars in Fitzpatrick Skin Types I – VI.
Key Metrics
A 1-point improvement in ECCA score in 90.2% of subjects.
A panel of blinded evaluators correctly identified post-treatment images for 89.4% of subjects.
Treating physicians also assessed subject level of improvement with a review of photography and showed 78% improvement.
average pain score of 4.4/10.
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.
FDA 510(k) Clearance Letter - AVAVA™ Skin Treatment System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 14, 2025
Avava Inc
Richard Bankowski
Executive VP of Global Clinical and Regulatory
275 2nd Ave
3rd Floor
Waltham, Massachusetts 02451
Re: K250402
Trade/Device Name: AVAVA™ Skin Treatment System
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: ONG
Dated: February 12, 2025
Received: February 12, 2025
Dear Richard Bankowski:
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 (the 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 available 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.
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K250402 - Richard Bankowski
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250402 - Richard Bankowski
Page 3
assistance/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,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.04.14 22:11:36 -04'00'
Tanisha Hithe
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K250402
Device Name: AVAVA™ Skin Treatment System
Indications for Use (Describe)
The AVAVA™ Skin Treatment System is indicated for use in the treatment of acne scars, and dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The AVAVA™ Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.
The AVAVA™ Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary K250402
Page 1 of 4
General Provisions
510(k) Owner's Name: AVAVA, Inc.
Address: 275 Second Avenue, Floor 3
Waltham, MA 02451
Contact Person: Richard Bankowski
EVP of Global Clinical and Regulatory
Phone Number: Office: (617) 912-2680
Fax Number: Not Applicable
Classification Name: Laser Surgical Instrument for Use in General and Plastic Surgery and Dermatology
Regulation: 21 CFR § 878.4810
Regulatory Class: II
Product Code: ONG
Proprietary Name: Avava Skin Treatment System
Common Name: Powered Laser Surgical Instrument with Microbeam/Fractional Output
Date Summary Prepared: April 9, 2025
Name of Predicate Device(s)
- Miria Skin Treatment System: K223871
Intended Use
The Avava Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The Avava Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.
Page 6
510(k) Summary K250402
General Provisions
510(k) Owner's Name: AVAVA, Inc.
Address: 275 Second Avenue, Floor 3
Waltham, MA 02451
Contact Person: Richard Bankowski
EVP of Global Clinical and Regulatory
Phone Number: Office: (617) 912-2680
Fax Number: Not Applicable
Classification Name: Laser Surgical Instrument for Use in General and Plastic Surgery and Dermatology
Regulation: 21 CFR § 878.4810
Regulatory Class: II
Product Code: ONG
Proprietary Name: Avava Skin Treatment System
Common Name: Powered Laser Surgical Instrument with Microbeam/Fractional Output
Date Summary Prepared: April 9, 2025
Name of Predicate Device(s)
- Miria Skin Treatment System: K223871
Intended Use
The Avava Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The Avava Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.
Page 1 of 4
Page 7
510(k) Summary K250402
Page 2 of 4
Device Description
The AVAVA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the AVAVA.
The AVAVA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.
The AVAVA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port.
The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.
Indications for Use
The AVAVA Skin Treatment System is indicated in the treatment of acne scars and for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The AVAVA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The AVAVA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
Summary of Technological Similarities/Differences
The intended use, technological characteristics, and operating principles of the AVAVA Skin Treatment System for the subject device and the predicate device are the same with the exception of the maximum output power. The Subject device has a 30W maximum output power whereas the predicate device has a 20W maximum output power. The purpose for the change in laser power is to increase treatment speed which is a highly desirable attribute. However, the pulse energy used for treatment remained unchanged from the previously cleared device, hence there is no anticipated increase in risk.
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510(k) Summary K250402
Page 3 of 4
With higher laser power, the pulse duration reduces to maintain the same laser energy. However, the range of pulse durations and the maximum pulse duration is the same as for the previously cleared device. We have shown through treatment of subjects in a clinical study, that the change in laser power does not change the geometry of the coagulated zones and does not result in any increased risk to patients.
Device Comparison
| Avava Skin Treatment System (Subject Device) K2505402 | MIRIA Skin Treatment System (Predicate Device) K221268 | |
|---|---|---|
| Operating principal | Scanned pulsed 1550nm laser energy directed into the skin via an operator controlled delivery system. | Scanned pulsed 1550nm laser energy directed into the skin via an operator controlled delivery system. |
| Laser source | 1550nm erbium glass diode pumped fiber laser | 1550nm erbium glass diode pumped fiber laser |
| Output power | 30W | 20W |
| Maximum pulse energy | 150 mJ | 150 mJ |
| Maximum pulse width | 12 ms | 12 ms |
| Tissue contact | Reusable sapphire cooled tip | Reusable sapphire cooled tip |
| Cooling mechanism | Continuous contact cooling | Continuous contact cooling |
| Software control | Yes | Yes |
| User interface | Touchscreen | Touchscreen |
Risk Analysis
Risk analysis was performed according to IEC 14971:2007 Medical Devices- Application of Risk Management to Medical Devices.
Summary of Performance Testing
-
Software verification and validation for those elements impacted by the changes were conducted according to the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) and IEC 62304:2006 +A1:2015, Ed. 1.0 Medical device software - Software life cycle processes.
-
Electrical Safety testing was conducted per ANSI AAMI ES 60601-1:2005(R)2012 and A1:2012 Medical Electrical Equipment Part 1: General requirements for basic safety
-
EMC Testing was conducted per IEC 60601-1-2: 2014-02 Medical electrical equipment - Part 1-2 General requirements for basic safety and essential performance
Page 9
510(k) Summary K250402
Page 4 of 4
Summary of Clinical Testing
A prospective clinical study was conducted to show the safety and efficacy of treating acne scars with the Avava Skin Treatment System.
The study enrolled and treated 47 subjects of Fitzpatrick Skin Type I-VI. 41 subjects returned for a follow-up visit post treatment to be included in efficacy analysis, 29 of which returned for a 3-month follow-up visit per-protocol. Subjects received anywhere between 1 to 6 treatments during the study and then began the follow-up process within the protocol, which included collection of photography after the treatment series was complete. Photographs were presented to a panel of evaluators who identified a 1-point improvement in ECCA score in 90.2% of subjects. A panel of blinded evaluators correctly identified post-treatment images for 89.4% of subjects. Treating physicians also assessed subject level of improvement with a review of photography and showed 78% improvement. Treatment was well tolerated by all subjects with an average pain score of 4.4/10.
Overall, the MIRIA Laser was found to be safe and effective for the treatment of Acne Scars in Fitzpatrick Skin Types I – VI.
Conclusion
The modified AVAVA Skin Treatment System has the same intended use, technological characteristics, and principle of operation as the predicate device. The modification to the microbeam shaping and the addition of connectivity raise no new issues of safety or efficacy as demonstrated by the risk analysis and performance data. The data show that the AVAVA Skin Treatment System performs in accordance with its specifications and requirements for both safety and effectiveness in similarity to the predicate device. The clinical study conducted to support the new indication for use of the treatment of acne scars showed that the device is both effective and safe to use on all skin types. Thus, the modified AVAVA Skin Treatment System and the existing AVAVA Skin Treatment System are substantially equivalent.