(214 days)
Not Found
No
The summary describes a laser system with software control for setting parameters, but there is no mention of AI, ML, image processing, or any data-driven decision-making or learning capabilities. The performance studies focus on safety, usability, and basic device function verification.
No
The "Intended Use" section clearly states the device is for "aesthetic and cosmetic applications," and for "removal of benign pigmented lesions," which are generally considered cosmetic or non-therapeutic aesthetic treatments, not for treating diseases or medical conditions. While it ablates, vaporizes, and coagulates soft body tissues, these actions are performed for aesthetic reasons rather than for diagnosing, curing, mitigating, treating, or preventing disease, which would classify it as therapeutic.
No
The device is described as a laser system intended to ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications, and for the removal of benign pigmented lesions. Its function is to treat, not diagnose.
No
The device description explicitly states that the system includes three main hardware components: Console, Tablet, and Handpiece, in addition to being software-controlled.
Based on the provided information, the PL-1 Skin Treatment System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a laser system intended to "ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications" and for "removal of benign pigmented lesions". This involves direct interaction with the patient's body (in vivo), not testing samples taken from the body (in vitro).
- Device Description: The description details a laser system with a handpiece that projects energy into the skin of a patient. This is consistent with an in vivo treatment device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the PL-1 Skin Treatment System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PL-1 Skin Treatment System is a 1064 nm laser system intended to ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications in the medical specialties of dermatology and plastic surgery. It is also indicated for removal of benign pigmented lesions including; nevus of Ota, café au lait spot, ephelides, solar lentigines), Becker's nevus, nevus spilus and treatment of common nevi..
The PL-1 Skin Treatment System is intended to be used by medical professionals and staff who are of lasers and who are familiar with the technology, operation of the system, and safety precautions.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONG
Device Description
The PL-1 Skin Treatment System is a 1064nm, Q-switched laser system. The system includes three (3) main components: Console, Tablet, and Handpiece. The Console houses the system control electronics, power distribution, contact cooling, and laser. The primary user interface for controlling the system through a touch screen graphical user interface. The Handpiece contains the optics, focusing components, and reference window assembly.
The PL-1 Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Handpiece 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 device is intended to be used by a suitably trained professional in a clinical 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
soft body tissues, 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; suitably trained professional in a clinical 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical Safety, Electromagnetic Compatibility, Biocompatibility and Laser Safety. Evaluation of the device was conducted by a nationally recognized testing laboratory (NRTL) and was found in compliance with the following standards: IEC 60601-1-2:2014 Ed 4.0, IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012, IEC 62304:2006 + A1:2015, Ed. 1.0, IEC 60601-1-6:2010, AMD1:2013, IEC 62366-1: 2015, IEC 60601-2-22: 2019, IEC 60825-1:2014, ISO 10993-1:2018.
Non-Clinical Performance Data: Usability testing compliant to FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (2016) and IEC 62366-1, and verification and validation of the PL-1 Skin Treatment System's laser energy, performance and control mechanisms. The performance of the PL-1 Skin Treatment System and related parameters of the predicate devices are substantially equivalent.
Software verification and validation testing was conducted, and documentation provided as recommended by FDA Guidance Content of Premarket Submissions for Software Contained in Medical Devices (2005) and IEC 62304. Device software verification and validation results were found acceptable for software release.
Biocompatibility of the patient contacting materials was established per FDA Guidance Use of International Standard ISO 10993-1 Biological evaluation of medical devices –Part 1: Evaluation and Testing Within a Risk Management Process (2018) and the referenced standard.
Animal studies and clinical performance testing were not deemed necessary as the device is using the same key technology, operating principles, and intended use as the predicate device.
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.
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 contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 28, 2022
Avava, Inc Jay Bhawalkar Chief Technology Officer 275 Second Avenue, Floor 3 Waltham, Massachusetts 02451
Re: K213726
Trade/Device Name: PL-1 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: GEX, ONG Dated: May 25, 2022 Received: May 27, 2022
Dear Jay Bhawalkar:
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 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, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213726
Device Name PL-1 Skin Treatment System
Indications for Use (Describe)
The PL-1 Skin Treatment System is a 1064 nm laser system intended to ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications in the medical specialties of dermatology and plastic surgery. It is also indicated for removal of benign pigmented lesions including; nevus of Ota, café au lait spot, ephelides, solar lentigines), Becker's nevus, nevus spilus and treatment of common nevi..
The PL-1 Skin Treatment System is intended to be used by medical professionals and staff who are of lasers and who are familiar with the technology, operation of the system, and safety precautions.
| 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
General Provisions
| 510(k) Owner's Name: | AVAVA, Inc. |
|---|---|
| Address: | 245 Second Avenue, Floor 3 Waltham, MA 02451 |
| Contact Person: | Jay Bhawalkar, Ph.D., Chief Technology Officer |
| Phone Number: | Office: 617-377-7961 |
| 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: | GEX, ONG |
| Proprietary Name: | PL-1 Skin Treatment System |
| Common Name: | Powered Laser Surgical Instrument with Microbeam Output |
| Date Summary Prepared: | May 26, 2022 |
Name of Predicate Device(s)
- Primary Predicate: Quanta Chrome, K202503
Intended Use
The PL-1 Skin Treatment System is a 1064 nm laser system intended to ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications in the medical specialties of dermatology and plastic surgery. It is also indicated for removal of benign pigmented lesions including; nevus of Ota, café au lait spot, ephelides, solar lentigines), Becker's nevus, nevus spilus and treatment of common nevi. The PL-1 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.
Device Description
The PL-1 Skin Treatment System is a 1064nm, Q-switched laser system. The system includes three (3) main components: Console, Tablet, and Handpiece. The Console houses the system control electronics, power distribution, contact cooling, and laser. The primary user interface for controlling the system through a touch screen graphical user interface. The Handpiece contains the optics, focusing components, and reference window assembly.
The PL-1 Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Handpiece 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 device is intended to be used by a suitably trained professional in a clinical setting. There are no sterile components.
4
Technological Characteristics
The PL-1 Skin Treatment System has the same intended use and similar indications for use, technological characteristics and operating principles as the Quanta Chrome system (Quanta systems) operating in the 1064 Q-switched, nanosecond mode with a microbeam handpiece. The design and components are very similar to the Quanta systemas shown in the following table. The differences are minor and do not raise any new issues of safety or efficacy of the PL-1 Skin Treatment System device as shown in the performance testing results.
| Characteristic | Subject Device | Primary Predicate | Substantial
Equivalence? |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | PL-1 Skin Treatment System | Chrome | NA |
| Manufacturer | AVAVA | Quanta | NA |
| 510k | K213726 | K202503 | NA |
| Classification | 878.4810 Laser surgical
instrument for use in general
and plastic surgery and in
dermatology | 878.4810 Laser surgical
instrument for use in general
and plastic surgery and in
dermatology | Yes, same classification |
| Product code | GEX, ONG | GEX | Yes, same code |
| Device class | II | II | Yes, same class |
| Intended use | Aesthetic and cosmetic
applications requiring ablation,
vaporization and coagulation of
body soft tissues in the medical
specialties of dermatology and
plastic surgery | Aesthetic, cosmetic and surgical
applications requiring incision,
excision, ablation, vaporization and
coagulation of body soft tissues in
the medical specialties of
dermatology, general, plastic and
oral surgery | Yes, same intended use
for aesthetic and cosmetic
applications |
| Indications | The PL-1 Skin Treatment system
is indicated for the removal of
benign pigmented lesions
including; nevus of Ota, café au
lait spot, ephelides, solar
lentigo (lentigines), Becker's
nevus, nevus spilus, and
treatment of common nevi. | The Quanta Chrome system
operating in 1064nm
nanosecond mode with
microbeam handpiece is
indicated for: Removal of dark
ink (black, blue and brown)
tattoos. Removal of benign
pigmented lesions including;
nevus of Ota, Café au lait spot,
Ephalides, solar lentigo
(lentigines), Becker Nevus,
Nevus spilus. Treatment of
common nevi. Removal or
lightening of unwanted hair Skin
resurfacing procedures for the
treatment of acne scars and
wrinkles. | Yes, same indication
for use for BPL based
on equivalence in
operating principle,
laser type, wavelength,
treatment parameters
and demonstrated
performance to
specifications |
| Characteristic | Subject Device | Primary Predicate | Substantial
Equivalence? |
| Operating Principles | | | |
| Focused
microbeams | Yes | Yes | Yes |
| Mechanism | Selective photothermolysis | Selective photothermolysis | Yes |
| Laser | | | |
| CDRH Laser Classification | Class 4 | Class 4 | Yes |
| Q-switched flash lamp
pumped laser | Yes | Yes | Yes |
| Wavelength (nm) | 1064 | 1064 | Yes |
| Maximum pulse energy
(mJ) | 850 | 800 | Yes, difference of 6% is
well under acceptable
tolerance of 20% for
single system per IEC
60601-2-22 |
| Nominal pulse width (ns) | 6 to 12 | 6 to 12 | Yes |
| Pulse repetition rate,
maximum (Hz) | 10 | 20 | Yes , repetition rate for
the subject device is a
subset of the cleared
specification for the
predicate device |
| Aiming beam | None | 635 nm | Yes, position at
intended treatment
site achieved through
specified means. |
| Treatment | | | |
| Optics | Focusing optics in
handpiece | Focusing optics in
handpiece | Yes, similar delivery of
focused laser energy |
| Tissue contact | Reference window | Distance gauge | Yes, treatment distance is
maintained through
specified means |
| Cooling mechanism | None | Integrated skin cooler for
optional use prior to laser
treatment | Yes, optional for
predicate system. |
| Energy delivery | Microbeam | Microbeam | Yes |
| Number of microbeams | 60 | 66 | Yes, similar number of
microbeams covering
same spot dimension |
| Spot diameter (mm) | 8 mm round | 8 mm round | Yes |
| Max fluence per
microbeam (J/cm²) | Up to 45 | Up to 44 | Yes |
| Output verification | Bench testing | Bench testing | Yes |
| Device
Characteristics | | | |
| User interface | Touchscreen | Touchscreen | Yes |
| Characteristic | Subject Device | Primary Predicate | Substantial
Equivalence? |
| Software Control | Yes | Yes | Yes |
| Laser trigger | Foot switch | Foot switch | Yes |
| Emergency shut-off | Yes | Yes | Yes |
| Safety | | | |
| FDA CDRH 21 CFR 1040 | Yes | Yes | Yes |
| Electrical safety
(IEC 60601-1) | Yes | Yes | Yes |
| Electromagnetic
compatibility
(IEC 60601-1-2) | Yes | Yes | Yes |
5
6
Risk Analysis
Risk analysis was performed according to IEC 14971:2007 Medical Devices- Application of Risk Management to Medical Devices, reviewed by a nationally recognized testing laboratory (NRTL), and found to be in compliance.
Summary of Performance Testing
Electrical Safety, Electromagnetic Compatibility, Biocompatibility and Laser Safety
Evaluation of the device was conducted by a nationally recognized testing laboratory (NRTL) and was found in compliance with the following standards:
- IEC 60601-1-2:2014 Ed 4.0 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical electrical . equipment - Part 1: General requirements for basic safety and essential performance
- IEC 62304:2006 + A1:2015, Ed. 1.0 Medical device software Software life cycle ● processes
- IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment Part 1-6: . General requirements for basic safety and essential performance - Collateral standard: Usability
7
- IEC 62366-1: 2015 Medical devices Part 1: Application of usability engineering . to medical devices
- IEC 60601-2-22: 2019 Medical electrical equipment Part 2-22: Particular . requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- . IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process
Non-Clinical Performance Data
The PL-1 Skin Treatment System performance characteristics have been evaluated through usability testing compliant to FDA Guidance Applying Human Factors and Usability Enqineering to Medical Devices (2016) and IEC 62366-1, and verification and validation of the PL-1 Skin Treatment System's laser energy, performance and control mechanisms. The performance of the PL-1 Skin Treatment System and related parameters of the predicate devices are substantially equivalent.
Software verification and validation testing was conducted, and documentation provided as recommended by FDA Guidance Content of Premarket Submissions for Software Contained in Medical Devices (2005) and IEC 62304. Device software verification and validation results were found acceptable for software release.
Biocompatibility of the patient contacting materials was established per FDA Guidance Use of International Standard ISO 10993-1 Biological evaluation of medical devices –Part 1: Evaluation and Testing Within a Risk Management Process (2018) and the referenced standard.
Animal studies and clinical performance testing were not deemed necessary as the device is using the same key technology, operating principles, and intended use as the predicate device.
8
Summary of Substantial Equivalence
The PL-1 Skin Treatment System and the predicate devices have the same intended use for the 1064 Q-switched nanosecond mode with microbeam handpiece. The PL-1 Skin Treatment System presents similar technological characteristics as its predicate devices, including the laser type, wavelength, and device design. Although there are minor differences in the details of the device design, they are not sufficient to raise new questions of safety or efficacy.
Conclusion
The PL-1 Skin Treatment System is as safe and effective as the predicate devices operating in the 1064 Q-switched nanosecond mode with a microbeam handpiece. The new device has similar intended use and indications for use, technological characteristics and the same principle of operation as the predicate devices. The minor design differences raise no new issues of safety or efficacy as demonstrated by the performance data. The data show that the PL-1 Skin Treatment System performs in accordance with its specifications and requirements for both safety and effectiveness in similarity to the predicate devices. Thus, the PL-1 Skin Treatment System and the predicates are substantially equivalent.