(148 days)
Not Found
No
The description focuses on the laser technology, cooling system, and user interface for parameter selection. There is no mention of AI, ML, image processing, or data-driven decision making within the device's operation.
Yes
The device is indicated for the treatment of inflammatory acne vulgaris, which is a medical condition, making it a therapeutic device.
No
This device is solely indicated for the treatment of inflammatory acne vulgaris, not for diagnosing it.
No
The device description clearly outlines a physical laser system with hardware components including a diode laser, power supplies, control electronics, cooling system, console with touchscreen, and a treatment handpiece with 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- AviClear's Function: The AviClear Laser System is a therapeutic device that directly treats acne vulgaris by delivering laser energy to the skin. It interacts with the patient's body directly to achieve a therapeutic outcome.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device's function is based on the physical interaction of laser energy with the sebaceous glands within the skin.
Therefore, the AviClear Laser System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AviClear Laser System is indicated for the treatment of mild to severe inflammatory acne vulgaris.
Product codes
GEX
Device Description
The AviClear Laser System is an infrared Indium Phosphide (InP) 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 energy 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
facial skin
Indicated Patient Age Range
16 to 40 years
Intended User / Care Setting
Prescription Use
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
Study-timepoint randomized (baseline, 4-week follow-up, and/or 12-week follow-up) sets of left and right 45° frontal photographs of each subject were sent to three trained and experienced acne lesion counters for independent counting of inflammatory (papules, pustules, and nodules) and noninflammatory (open and closed comedones) acne lesions. The acne lesion counters were blinded to the study design, including the success criteria and study timepoints being evaluated. The median of the three count values for each facial side and lesion type was assigned to the subject for each study timepoint.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
IDE-approved, prospective, multi-center, significant-risk clinical study.
104 subjects (ITT cohort), 89 subjects (PP cohort).
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 a subject with ≥50% fewer inflammatory acne lesions 12 weeks after their final treatment visit than at baseline.
Primary Effectiveness Analysis (ITT cohort, n=104):
- Median and mean inflammatory lesion counts at baseline: 56 and 63.4 ± 40.2.
- Median and mean reductions at 4-week follow-up: 41.5% and 37.1% ± 28.5% (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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 24, 2022
Cutera, Inc. Amogh Kothare VP, Clinical and Regulatory Affairs 3240 Bayshore Blvd. Brisbane, California 94005
Re: K213461
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: October 26, 2021 Received: October 27, 2021
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.
1
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 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 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.
Purva Pandya, D.Eng. 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) K213461
Device Name AviClear Laser System
Indications for Use (Describe)
The AviClear Laser System is indicated for the 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
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 21, 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: | Candela Smoothbeam Laser System (K041242) |
| Indications for Use: | The AviClear Laser System is indicated for the treatment of mild to severe |
| inflammatory acne vulgaris. | |
| Device Description: | The AviClear Laser System is an infrared Indium Phosphide (InP) 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 energy 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
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: Safety - -General Requirements for 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
5
510(K) Summary
Results of Clinical An IDE-approved, prospective, multi-center, significant-risk clinical study Study: was conducted under IRB oversight to assess the safety and effectiveness of the 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 a subject with ≥50% fewer inflammatory acne lesions 12 weeks after their final treatment visit than at baseline.
104 subjects, 59 female (57%) and 45 male (43%), aged 16 to 40 years (avg. 22.2 ± 5.5 years), diagnosed with Mild (n=1), Moderate (n=81), or Severe (n=22) acne vulgaris were enrolled and entered the Treatment Phase of the study at 7 US sites. In the Treatment Phase, subjects received a total of 304 treatments, spaced 2 to 5 weeks apart, to facial skin and were followed 10 (±5) days after each treatment visit via phone and at 4 (-1/+2) weeks and 12 (±2) weeks after their final treatment visit. After completing the 12-week followup visit, the subjects entered the Follow-up Phase of the study and are scheduled for follow-up visits at 26 (±3) weeks and 52 (±4) weeks post-final treatment.
Standardized photographs of subjects were taken at baseline and at 4- and 12-week follow-up visits. Prior to a subject being formally enrolled, baseline photographs of the subject were sent to a panel of three trained expert physicians for Investigator Global Assessment (IGA) grading and, if the median of the three baseline IGA grades was at least Mild, the subject was enrolled. Subject photographs taken at the 4- and 12-week follow-up visits were sent to the same panel of trained expert physicians for independent IGA grading with the median of the three IGA grades being assigned to the subject for that study timepoint.
Study-timepoint randomized (baseline, 4-week follow-up, and/or 12-week follow-up) sets of left and right 45° frontal photographs of each subject were sent to three trained and experienced acne lesion counters for independent counting of inflammatory (papules, pustules, and nodules) and noninflammatory (open and closed comedones) acne lesions. The acne lesion counters were blinded to the study design, including the success criteria and study timepoints being evaluated. The median of the three count values for each facial side and lesion type was assigned to the subject for each study timepoint.
All subjects who were enrolled and received at least one treatment with the investigational Cutera 1726 nm laser system were included in the Safety/Intent-to-Treat (ITT) Cohort. The Per-Protocol (PP) Cohort was defined as the group of subjects who completed all treatment procedures and who completed the 12-week post-final treatment visit without any major protocol deviations.
Subjects were also assigned into subgroups by Age (16-19 years, 20-35 years, or >35 years), Sex (female or male), Fitzpatrick Skin Type (FST I-III, FST IV-V, or FST VI), and baseline IGA (Mild, Moderate, or Severe), and Responder rates and the frequency of device related adverse events within these subgroups were compared.
6
510(K) Summary
Primary Effectiveness Analysis
For the ITT cohort (n=104), the median and mean inflammatory lesion counts at baseline were 56 (Min 14. Max 297) and 63.4 ± 40.2. respectively. There were median and mean reductions of 41.5% and 37.1% ± 28.5%, respectively, in the inflammatory lesion counts from baseline (p35 years (n=2) was 50%; however, the result was not statistically significant (p>0.999).
Responder rates in Sex subgroups female (n=59) and male (n=45) were 76.3% (95% Cl: 63%, 86%) and 80% (95% Cl: 65%, 90%), respectively. Both results were statistically significant (p0.999).
Responder rates in Baseline IGA subgroups Moderate (n=81) and Severe (n=22) were 82.2% (95% Cl: 70%, 88%) and 72.7% (50%, 89%), respectively. Both results were statistically significant (p