(269 days)
Not Found
No
The document describes a laser device with different handpieces and wavelengths for dermatological procedures. It details the device's physical components, user interface, and intended uses, but makes no mention of AI or ML technology for image processing, parameter optimization, or any other function.
Yes
The device is used for dermatological procedures and "treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia," as well as "treatment of melasma, striae, acne scars and surgical scars," indicating it is intended to provide therapy.
No
The provided text describes the device's indications for use as performing procedures like skin resurfacing, treatment of wrinkles, and coagulation/ablation of soft tissue, which are therapeutic rather than diagnostic actions.
No
The device description explicitly states it is a medical device containing two laser wavelengths and describes physical components like a main unit, articulated mirror arm, applicator, and touch screen. This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 the body (in vitro).
- Device Function: The BTL-754 device is a laser system used for dermatological procedures performed directly on the patient's skin (in vivo). It uses laser energy to coagulate, resurface, and ablate soft tissue.
- Intended Use: The intended use clearly describes procedures performed on the skin for therapeutic and cosmetic purposes, not for analyzing biological samples.
- Device Description: The description details a laser system with handpieces and a main unit, consistent with a therapeutic or surgical device, not a diagnostic one.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD testing.
Therefore, the BTL-754 device falls under the category of a therapeutic or surgical medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BTL-754 device with BTL-754-4 handpiece has the following indications for use:
The 2940nm Fractional handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The 1540nm Fractional handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The combined 1540mm and 2940mm Fractional handpiece is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONG
Device Description
The BTL-754 is a medical device containing two laser wavelengths. A laser is a device that can generate light in the visible or invisible part of the electromagnetic spectrum. The generation of radiation occurs by means of so-called stimulated emission, thanks to which its beam has specific properties - the laser beam is well directed and can propagate over long distances without much divergence. It can also be focused into a very small spot where a very high intensity is achieved.
The BTL-754 consists of a main unit, articulated mirror arm and applicator. The main unit is equipped with a color touch screen with a wide that makes the device easy to use. The onscreen information informs the operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about therapy parameters. The device is equipped with the Emergency laser stop button for immediate termination of the laser emission.
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
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)
Non-clinical Testing (Performance, Bench Testing)
The device has been found to comply with applicable medical device safety standards:
- IEC 60601-1:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2020 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-22:2019 Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diaqnostic laser equipment
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation
Sterilization, cleaning and disinfection validation:
- ISO 11737-1:2018+A1:2021 Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
- ISO 11737-2:2019 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ISO 17664-1:2021 "Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
- ISO 17665:2024 Sterilization of health care products Moist Heat -Requirements for the development, validation and routine control of a sterilization process for medical devices
Basic device performance verified by manufacturer in:
- Measuring of pulse repetition frequency test -
- -Laser output accuracy test
Clinical Testing
Not applicable to this submission
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
January 30, 2025
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
BTL Industries, Inc. David Chmel CEO North America 362 Elm Street Marlborough, Massachusetts 01752
Re: K241270
Trade/Device Name: Btl-754 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: December 26, 2024 Received: December 26, 2024
Dear David Chmel:
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.
1
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 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-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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory
2
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,
Digitally signed by YAN FU -S
YAN FU -S Date: 2025.01.30 09:00:31
-05'00'
for 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
3
Indications for Use
510(k) Number (if known) K241270
Device Name BTL-754
Indications for Use (Describe)
The BTL-754 device with BTL-754-4 handpiece has the following indications for use:
The 2940nm Fractional handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The 1540nm Fractional handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The combined 1540mm and 2940mm Fractional handpiece is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
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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Image /page/4/Picture/0 description: The image contains the logo for BTL Industries. The logo consists of three nested squares with the letters "BTL" inside the leftmost square. To the right of the logo is the text "BTL Industries" in a sans-serif font.
510(k) Summary K241270
General Information
| Sponsor: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|---------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | David Chmel
BTL Industries, Inc.
chmel@btlnet.com |
| Summary Preparation | |
Device
Date:
| Trade/Proprietary Name: | BTL-754 |
|---|---|
| Primary Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Classification Regulation: | 21 CFR 878.4810, Class II |
| Classification Product Code: | GEX, ONG |
27 January 2025
5
Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three squares, each nested inside the other, with the letters "BTL" inside the innermost square. The text "BTL Industries" is written in a sans-serif font.
Legally Marketed Predicate Device
The BTL-754 is a state-of-the-art high-frequency energy device with accessories, and is substantially equivalent to the following products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:
Predicate device name: Palomar Icon Aesthetic System Original 510(k) Sponsor: Cynosure, Inc. 510(k) Number: K142376
Product Description
The BTL-754 is a medical device containing two laser wavelengths. A laser is a device that can generate light in the visible or invisible part of the electromagnetic spectrum. The generation of radiation occurs by means of so-called stimulated emission, thanks to which its beam has specific properties - the laser beam is well directed and can propagate over long distances without much divergence. It can also be focused into a very small spot where a very high intensity is achieved.
The BTL-754 consists of a main unit, articulated mirror arm and applicator. The main unit is equipped with a color touch screen with a wide that makes the device easy to use. The onscreen information informs the operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about therapy parameters. The device is equipped with the Emergency laser stop button for immediate termination of the laser emission.
Technological characteristics
The BTL-754 device has similar technological characteristics compared to its predicate devices. The BTL-754 device and the predicates are comprised of a system console and applicators.
6
Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares that are nested inside each other. The letters "BTL" are written in white inside the innermost square. To the right of the logo, the words "BTL Industries" are written in gray.
Indications for Use
The BTL-754 device with BTL-754-4 handpiece has the following indications for use:
The 2940nm Fractional handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The 1540nm Fractional handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The combined 1540nm and 2940nm Fractional handpiece is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
Non-clinical Testing (Performance, Bench Testing)
The device has been found to comply with applicable medical device safety standards:
- IEC 60601-1:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2020 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-22:2019 Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diaqnostic laser equipment
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation
Sterilization, cleaning and disinfection validation:
- ISO 11737-1:2018+A1:2021 Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
- ISO 11737-2:2019 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares with the letters "BTL" inside the leftmost square. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font. The logo appears to be for a company in the industrial sector.
- ISO 17664-1:2021 "Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
- ISO 17665:2024 Sterilization of health care products Moist Heat -Requirements for the development, validation and routine control of a sterilization process for medical devices
Basic device performance verified by manufacturer in:
- Measuring of pulse repetition frequency test -
- -Laser output accuracy test
Clinical Testing
Not applicable to this submission
Comparison with the Predicate Device
| 510(k) number | K241270 | K142376 |
|---|---|---|
| Device name | BTL-754 | Palomar Icon Aesthetic System |
| Company name | BTL Industries, Inc. | Cynosure, Inc. |
| Type | Subject device | Predicate device |
| General & Plastic Surgery | General & Plastic Surgery | |
| 21 CFR 878.4810 | 21 CFR 878.4810 | |
| Product Code | ||
| and Regulation | ONG - Powered Laser Surgical | |
| Instrument With | ||
| Microbeam\Fractional Output | ONG - Powered Laser Surgical | |
| Instrument With | ||
| Microbeam\Fractional Output | ||
| GEX - Powered Laser Surgical | ||
| Instrument | GEX - Powered Laser Surgical | |
| Instrument |
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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares with the letters "BTL" inside the leftmost square. To the right of the logo is the text "BTL Industries" in a sans-serif font.
| 2940nm | ||
|---|---|---|
| Indications for | ||
| Use | The 2940nm Fractional | |
| handpiece is intended for use in | ||
| dermatological procedures | ||
| requiring coagulation, resurfacing, | ||
| and ablation of soft tissue. | ||
| Procedures include skin | ||
| resurfacing and treatment of | ||
| wrinkles, rhytides, furrows, fine | ||
| lines, textural irregularities, | ||
| pigmented lesions, and vascular | ||
| dyschromia. | The 2940 Fractional Ablative Laser | |
| Handpiece is intended for use in | ||
| dermatological procedures | ||
| requiring coagulation, resurfacing, | ||
| and ablation of soft tissue. | ||
| Procedures include skin | ||
| resurfacing and treatment of | ||
| wrinkles, rhytides, furrows, fine | ||
| lines, textural irregularities, | ||
| pigmented lesions, and vascular | ||
| dyschromia. | ||
| Laser media | Er YAG | Er YAG |
| Wavelength | 2940nm | 2940nm |
| Output mode | Pulsed | Pulsed |
| Pulse width | 0.2 – 1.5 ms | 0.25, 3, 5 ms |
| Repetition rate | 1-3 Hz | Up to 6 Hz |
| Application | ||
| pattern (dots) | 10x10 (64mB/cm2) | 6x6 (178mB/cm2) |
| 6x6 (469mB/cm2) | ||
| 10x10 (169mB/cm2) | ||
| Microbeam | ||
| size | 250 μm +/-20% | 250 μm |
| Fluence | ||
| Energy/ | ||
| microbeam | Up to 24.5mJ/mB | Up to 24mJ/mB |
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Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three nested squares, each rotated 45 degrees, and the text is in a sans-serif font and is gray in color.
| 1540nm | ||
|---|---|---|
| Indications for | ||
| Use | The 1540nm Fractional handpiece | |
| is intended for use in coagulation | ||
| of soft tissue, skin resurfacing | ||
| procedures as well as treatment of | ||
| melasma, striae, acne scars and | ||
| surgical scars. | The 1540 Fractional | |
| Non-ablative Laser Handpiece | ||
| is intended for use in coagulation | ||
| of soft tissue, skin resurfacing | ||
| procedures as well as treatment of | ||
| melasma, striae, acne scars and | ||
| surgical scars. | ||
| Laser source | Er:Glass | Er:Glass |
| Wavelength | 1540 nm | 1540 nm |
| Output mode | Pulsed | Pulsed |
| Pulse width | 4-7 ms | 10, 15 ms |
| Repetition rate | 1-3 Hz | Up to 1.5 Hz |
| Application | ||
| pattern (dots) | 10x10 (64mB/cm2) | Ø15 (320mB/cm2) |
| Ø15 (115mB/cm2) | ||
| 12x12 (25mB/cm2) | ||
| Microbeam | ||
| size | 300 µm ±30% | Up to 270 µm |
| Energy/ | ||
| microbeam | Up to 28mJ/mB | 3mJ/mB - 70mJ/mB |
10
Image /page/10/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares on the left side of the image. The text "BTL Industries" is on the right side of the image.
| 1540nm and 2940nm | ||
|---|---|---|
| Indications for | ||
| Use | The combined 1540nm and | |
| 2940nm Fractional handpiece | ||
| is intended for dermatological | ||
| procedures requiring coagulation, | ||
| resurfacing, and ablation of soft | ||
| tissue. Procedures include skin | ||
| resurfacing and treatment of | ||
| wrinkles, rhytides, furrows, fine | ||
| lines, textural irregularities, | ||
| dyschromia and pigmented | ||
| lesions. | The 1540 Fractional Non-ablative | |
| Laser and 2940 Fractional Ablative | ||
| Laser Handpiece combined treatment | ||
| is intended for dermatological | ||
| procedures requiring coagulation, | ||
| resurfacing, and ablation of soft | ||
| tissue. Procedures include skin | ||
| resurfacing and treatment of | ||
| wrinkles, rhytides, furrows, fine | ||
| lines, textural irregularities, | ||
| dyschromia and pigmented | ||
| lesions. |
Substantial Equivalence
The BTL-754 device has the same intended use as its predicate device. The technological characteristics of the predicate device are comparable to the BTL-754 device. Any differences between the predicate device and BTL-754 have no significant influence on safety and effectiveness of the BTL-754 device. Therefore, the BTL-754 is substantially equivalent to the predicate device.
Conclusion
Based upon the intended use and known technical information provided in this pre-market notification, the BTL-754 device has been shown to be substantially equivalent to currently marketed predicate device K142376.