(28 days)
No
The document describes a laser scanner accessory for CO2 lasers and focuses on its compatibility and safety testing, with no mention of AI or ML capabilities.
Yes
The device is used for ablation, vaporization, excision, and coagulation of soft tissue, including laser skin resurfacing for wrinkles, rhytids, furrows, and scars, which are all therapeutic interventions used to treat medical conditions or symptoms.
No
This device is indicated for ablation, vaporization, excision, and coagulation of soft tissue, primarily in dermatology and plastic surgery, which are therapeutic and surgical functions, not diagnostic.
No
The device description explicitly states it is composed of hardware components: a "HiScan SCAR 3 head" and a "HiScan SCAR 3 cable." Performance studies also include electrical safety, EMC, and laser safety tests, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SCAR 3 scanner is used for ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery. These are all procedures performed directly on the patient's body.
- Device Description: The device is a scanner that connects to a CO2 laser to deliver laser energy to the tissue.
- Lack of mention of in vitro testing: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body. IVD devices are specifically designed for testing samples in vitro.
The device is a therapeutic device used for surgical and cosmetic procedures, not a diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for Use
The SCAR 3 scanner, when used with DEKA CO2 lasers, is indicated for ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery.
The SCAR 3 scanner, when used with DEKA CO2 lasers, is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows:
-The ablation, vaporization, excision, excision, and coagulation of soft tissue in the performance of laser burn debridement
-Laser skin resurfacing (ablation and/or vaporization) for treatment of:
· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)
-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- Acne scars
- · Surgical scars
Product codes
GEX
Device Description
The SCAR 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers.
The SCAR 3 is composed of the following components:
-
HiScan SCAR 3 head
-
HiScan SCAR 3 cable
Laser emission parameters are selected through the GUI of the DEKA laser device to whom the scanner is connected.
Shape and size of the scanning area may also be selected by using the three keys on the scanning head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue in dermatology and plastic surgery; laser burn debridement; skin; soft tissue
Indicated Patient Age Range
Not Found
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)
The following tests have been performed on the modified device:
- . Electrical safety tests according to AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, Cl:2009/(R)2012 and A2:2010/(R)2012 – Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- EMC Tests according to IEC 60601-1-2 Ed. 4.1 :2020 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests,
- Laser safety tests according to IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical ● equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- . Laser emission specification validation tests
Key Result: Based on the comparison of indications for use and the technological characteristics, we can conclude that SCAR 3 scanner is as safe, as effective, and performs as well as the legally marketed predicate device (K211362).
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.
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.
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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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
June 2, 2023
El.en Electroinc Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50041 Italy
Re: K231309
Trade/Device Name: Scar 3 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: April 20, 2023 Received: May 5, 2023
Dear Paolo Peruzzi:
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
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Indications for Use
510(k) Number (if known)
Device Name SCAR 3
Indications for Use (Describe)
The SCAR 3 scanner, when used with DEKA CO2 lasers, is indicated for ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery.
The SCAR 3 scanner, when used with DEKA CO2 lasers, is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows:
-The ablation, vaporization, excision, and coagulation of soft tissue in the performance of laser burn debridement
-Laser skin resurfacing (ablation and/or vaporization) for treatment of:
· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)
-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- Acne scars
- · Surgical scars
| 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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510 (K) Summary
SCAR 3 SCANNER FOR DEKA CO2 LASERS - Special 510(k)
Submitter:
El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy
Contact:
Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it
Date Summary Prepared:
April 20, 2023
Device Trade Name:
SCAR 3
Common Name:
Medical laser scanning unit
Classification Name:
Powered laser surgical instrument (GEX)
Classification Number:
21 CFR 878.4810
Predicate Devices:
SCAR 3 (K211362)
Device Description:
The SCAR 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers.
The SCAR 3 is composed of the following components:
-
HiScan SCAR 3 head
-
HiScan SCAR 3 cable
Laser emission parameters are selected through the GUI of the DEKA laser device to whom the scanner is connected.
Shape and size of the scanning area may also be selected by using the three keys on the scanning head.
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The modification to the device consists in the extension of the DEKA CO2 laser whom the SCAR 3 scanner can be connected to. The predicate device SCAR 3 (K211362) has been cleared to be used specifically in conjunction with DEKA Smartxide family; the proposed SCAR 3 scanner can be connected to all DEKA CO2 lasers.
The indications for use of the modified device remain the same. Modification only extends the range of CO2 laser the scanner can be used with.
Indications for Use:
The SCAR 3 scanner, when used with DEKA CO2 lasers, is indicated for ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery.
The SCAR 3 scanner, when used with DEKA CO2 lasers, is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows:
-The ablation, vaporization, excision, incision, and coagulation of soft tissue in the performance of laser burn debridement
-Laser skin resurfacing (ablation and/or vaporization) for treatment of:
-
· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)
-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: -
Acne scars
-
· Surgical scars
Substantial equivalence discussion:
The SCAR 3 scanner when used with DEKA CO2 lasers is substantially equivalent to a legally marketed device, SCAR 3 (K211362).
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| Proposed 510(k) Device | Predicate Device | Comparison | |
|---|---|---|---|
| SCAR 3 | SCAR 3 | ||
| Device Trade Name | K211362 | ||
| Indications for use | The SCAR 3 scanner, when used with DEKA CO2 lasers, is | ||
| indicated for ablation, vaporization, excision, incision, and | |||
| coagulation of soft tissue in dermatology and plastic surgery. | The SCAR 3 scanner, when used with DEKA Smartxide family | ||
| lasers (K180193), is indicated for ablation, vaporization, | |||
| excision, incision, and coagulation of soft tissue in | |||
| dermatology and plastic surgery. | Indications for use | ||
| are the same. | |||
| Modification only | |||
| extend the range | |||
| of CO2 laser the | |||
| scanner can be | |||
| used with | |||
| The SCAR 3 scanner, when used with DEKA CO2 lasers, is | |||
| indicated for use in the performance of specific applications in | |||
| dermatology and plastic surgery as follows: | The SCAR 3 scanner, when used with DEKA Smartxide family | ||
| lasers (K180193), is indicated for use in the performance of | |||
| specific applications in dermatology and plastic surgery as | |||
| follows: | |||
| -The ablation, vaporization, excision, incision, and coagulation | |||
| of soft tissue in the performance of laser burn debridement | -The ablation, vaporization, excision, incision, and | ||
| coagulation of soft tissue in the performance of laser burn | |||
| debridement | |||
| -Laser skin resurfacing (ablation and/or vaporization) for | |||
| treatment of: | |||
| • Wrinkles, rhytids, and furrows (including fine lines and | |||
| texture irregularities) | -Laser skin resurfacing (ablation and/or vaporization) for | ||
| treatment of: | |||
| -Laser skin resurfacing (ablation and/or vaporization) of soft | |||
| tissue for the reduction, removal, and/or treatment of: | • Wrinkles, rhytids, and furrows (including fine lines and | ||
| texture irregularities) | |||
| • Acne scars | |||
| • Surgical scars | -Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: | ||
| • Acne scars | |||
| • Surgical scars | |||
| Product code | GEX | GEX | Identical |
| Laser Wavelength | 10600 nm | 10600 nm | Identical |
| Pulse Energy | 2.5-150 mJ | 2.5-150 mJ | Identical |
| Spot Sizes | 0.12 mm | 0.12 mm | Identical |
| Pulse Duration | 0.1-2.5 ms | 0.1-2.5 ms | Identical |
| Scanning Area | Max 10*10 mm | Max 10*10 mm | Identical |
| Density (spots per scan %) | 1%-25 % | 1%-25 % | Identical |
| Frequency (Hz) | 150-450 | 150-450 | Identical |
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The modification on SCAR 3 does not adversely affect safety and effectiveness of the scanner unit; proposed SCAR 3 and cleared SCAR 3 (K211362) share the same indications for use, principle of operation, specifications and performances.
Performance Data:
The following tests have been performed on the modified device:
- . Electrical safety tests according to AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, Cl:2009/(R)2012 and A2:2010/(R)2012 – Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- EMC Tests according to IEC 60601-1-2 Ed. 4.1 :2020 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests,
- Laser safety tests according to IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical ● equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- . Laser emission specification validation tests
Conclusion:
Based on the comparison of indications for use and the technological characteristics, we can conclude that SCAR 3 scanner is as safe, as effective, and performs as well as the legally marketed predicate device (K211362).