(88 days)
Not Found
No
The device description focuses on the physical components and laser technology, with no mention of AI/ML algorithms for image processing, treatment parameter selection, or other functions. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device description and intended use clearly state that the AviClear Laser System is used for the "long-term treatment of mild to severe inflammatory acne vulgaris," which is a medical condition, making it a therapeutic device.
No.
The AviClear Laser System is described as a treatment device for acne vulgaris, not a device used to diagnose medical conditions.
No
The device description clearly outlines a hardware system including a laser, power supplies, control electronics, cooling system, console with touchscreen, and a treatment handpiece with integrated scanner, cooling window, and pressure sensors. This is not a software-only device.
Based on the provided information, the AviClear Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- AviClear's Function: The description clearly states that the AviClear Laser System is a laser device that delivers energy to the skin to treat acne vulgaris. It works by heating sebaceous glands within the skin.
- Lack of Sample Analysis: There is no mention of the device analyzing any samples taken from the patient's body. It directly interacts with the patient's skin.
Therefore, the AviClear Laser System is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
Product codes
GEX
Device Description
The AviClear Laser System is an infrared diode laser device with a nominal wavelength of 1726 nm. Similar to other well-established infrared laser devices, the device uses a combination of the treatment spot size, beam characteristics, and tissue absorption and scattering coefficients at the output wavelength to deliver energy to tissues at depth. The wavelength of the laser energy, when combined with the pre, parallel (during energy delivery), and post cooling of epidermal and superficial dermal structures, causes selective heating of dermal tissue at different depths. The 1726 nm laser enerqy heats the chromophore, sebum within sebaceous glands, which results in controlled thermal injury of the sebaceous glands, the ultimate treatment target, thus reducing or eliminating sebum production and causing an improvement in acne vulgaris.
The diode laser and associated beam delivery optics, laser and electronics power supplies, control electronics, and cooling system are housed inside a console equipped with a touchscreen user interface. The laser treatment parameters are selected using the touchscreen.
The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern; a temperature-controlled skincontact cooling window to provide thermal protection for the epidermis and superficial dermis and through which energy is delivered to the patient; and skin-contact pressure sensors that enable laser energy delivery when the system is in Ready mode and the footswitch is depressed.
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
16 to 40 years
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)
Data for the clinical study was previously submitted under K213461, resulting in FDA 510k clearance for the treatment of mild to severe inflammatory acne vulqaris. This is a prospective, multi-center, clinical study to assess the safety and effectiveness of the Cutera AviClear Laser System for the treatment of mild to severe acne vulgaris. The study's primary effectiveness objective was to show more that than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with >=50% fewer inflammatory acne lesions with respect to baseline. Safety was assessed by a review of the totality of all reported adverse events and their resolutions, including assessments of treatment discomfort.
104 subjects, 57% female and 43% male, 16 to 40 years (avg. 22.2 +/- 5.5), diagnosed with mild, moderate, and severe acne vulgaris were enrolled. Subjects received up to 3 treatments and were followed up through 52weeks post final treatment, with 12-weeks being primary end-point.
Details surrounding the Primary, Secondary Effectiveness as well as Safety Analysis have been outlined in the previous 510(K) summary submitted under K213461.
Long Term Effectiveness Analysis: At the 52-week post-finaltreatment follow-up visit, 91.5% of subjects achieved treatment success (p
§ 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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
June 6, 2023
Cutera, Inc. Amogh Kothare VP, Clinical and Regulatory Affairs 3240 Bayshore Blvd. Brisbane, California 94005
Re: K230660
Trade/Device Name: AviClear Laser 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: GEX Dated: March 10, 2023 Received: March 10, 2023
Dear Amogh Kothare:
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,
Jianting Wang -S
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
2
Indications for Use
510(k) Number (if known) K230660
Device Name
AviClear Laser System
Indications for Use (Describe)
The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
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3
K230660 510(k) Summary
This 510(k) Summary of safety and effectiveness for the AviClear Laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) Summary.
| Applicant: | Cutera, Inc. |
|---|---|
| Address: | 3240 Bayshore Blvd., Brisbane, CA 94005 |
| Contact Person: | Amogh Kothare |
| akothare@cutera.com | |
| m. (415) 690-6796 | |
| o. (415) 657-5730 | |
| f. (415) 715-3730 | |
| Preparation Date: | March 10, 2022 |
| Device Trade Name: | AviClear Laser System |
| Common Name: | Dermatology Laser |
| Classification Name: | Powered Laser Surgical Instrument, GEX, 21 CFR 878.4810 |
| Legally Marketed | |
| Predicate Device: | AviClear Laser System (K213461) |
| Indications for Use: | The AviClear Laser System is indicated for the long-term treatment of mild |
| to severe inflammatory acne vulgaris. | |
| Device Description: | The AviClear Laser System is an infrared diode laser device with a nominal |
| wavelength of 1726 nm. Similar to other well-established infrared laser | |
| devices, the device uses a combination of the treatment spot size, beam | |
| characteristics, and tissue absorption and scattering coefficients at the |
e output wavelength to deliver energy to tissues at depth. The wavelength of the laser energy, when combined with the pre, parallel (during energy delivery), and post cooling of epidermal and superficial dermal structures, causes selective heating of dermal tissue at different depths. The 1726 nm laser enerqy heats the chromophore, sebum within sebaceous glands, which results in controlled thermal injury of the sebaceous glands, the ultimate treatment target, thus reducing or eliminating sebum production and causing an improvement in acne vulgaris.
The diode laser and associated beam delivery optics, laser and electronics power supplies, control electronics, and cooling system are housed inside a console equipped with a touchscreen user interface. The laser treatment parameters are selected using the touchscreen.
The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern; a temperature-controlled skincontact cooling window to provide thermal protection for the epidermis and superficial dermis and through which energy is delivered to the patient; and skin-contact pressure sensors that enable laser energy delivery when the system is in Ready mode and the footswitch is depressed.
4
Section 7 510(k) Summary
- Performance Data: IEC 60601-1/A1:2012 Medical Electrical Equipment - Part 1: ● General Requirements for Safety
- IEC 60601-1-6:2010/A1:2013 Medical electrical equipment -O Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
- IEC 60601-2-22:2007/A1:2012 Medical Electrical Equipment - O Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories
- IEC 60825-1:2014 Safety of laser products Part 1: Equipment o classification and requirements
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: ● General Requirements for Safety - Collateral Standard: Electromagnetic Disturbances
- Software Verification and Validation Testing ●
- Biocompatibility testing of patient-contact materials according to ISO-● 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- Data for the clinical study was previously submitted under K213461, Results of Clinical Study: resulting in FDA 510k clearance for the treatment of mild to severe inflammatory acne vulqaris. This is a prospective, multi-center, clinical study to assess the safety and effectiveness of the Cutera AviClear Laser System for the treatment of mild to severe acne vulgaris. The study's primary effectiveness objective was to show more that than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline. Safety was assessed by a review of the totality of all reported adverse events and their resolutions, including assessments of treatment discomfort.
104 subjects, 57% female and 43% male, 16 to 40 years (avg. 22.2 ± 5.5), diagnosed with mild, moderate, and severe acne vulgaris were enrolled. Subjects received up to 3 treatments and were followed up through 52weeks post final treatment, with 12-weeks being primary end-point.
Details surrounding the Primary, Secondary Effectiveness as well as Safety Analysis have been outlined in the previous 510(K) summary submitted under K213461.
- . Long Term Effectiveness Analysis: At the 52-week post-finaltreatment follow-up visit, 91.5% of subjects achieved treatment success (p