(406 days)
Not Found
No
The summary describes a laser system with standard components and functionalities, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for medical procedures such as coagulation, vaporization, ablation, and cutting of soft tissue, which directly treats or alters a physiological process.
No
The device is indicated for surgical procedures like coagulation, vaporization, ablation, and cutting of soft tissue, not for diagnosing conditions.
No
The device description explicitly states it is a pulsed Er:YAG laser system comprising a main console unit, detachable handpieces, and a footswitch, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for coagulation, vaporization, ablation, or cutting of soft tissue (skin) using a laser. This is a direct treatment or surgical procedure performed on a patient's body.
- Device Description: The device is a laser system with handpieces and a footswitch, designed to deliver laser energy to tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information about a physiological or pathological state. This device does not perform any such analysis of specimens.
The MCL 31 Dermablate System is a therapeutic medical device used for surgical and dermatological procedures.
N/A
Intended Use / Indications for Use
The MCL 31 Dermablate System with its accessories is indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).
The MCL 31 Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
Product codes
GEX
Device Description
The MCL 31 Dermablate System is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, detachable handpieces, and a footswitch. The MCL 31 Dermablate System can be operated with micro beam and non-micro beam handpieces. The system incorporates a suction unit for the safe removal of laser plume. The laser is fired with a foot-operated switch (footswitch).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).
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 performance data were applied in support of the substantial equivalence determination:
- . EN 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- EN/IEC 60825-1: Safety of laser products - Part 1: Equipment classification, and requirements
- IEC 62304: Medical Device Software - Software life cycle processes
- ISO 14971: Medical devices - Applications of risk management to medical devices
Biocompatibility testing was also conducted for the MY JULIET handpiece in accordance with:
- EN/ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing ● within a risk management process
- ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytoxicity
- ISO 10993-10: Biological evaluation of medical devices - Part 10 Tests for irritation and skin sensitization
- . ISO 10993-23: Biological evaluation of medical devices - Part 23 Tests for irritation.
Software verification and validation testing was conducted, and documentation is provided in this submission, as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Biocompatibility: The biocompatibility of MCL 31 Dermablate System and compatible handpieces with the extended indications is established based on the legally marketed predicate devices. For the MY JULIET handpiece testing was conducted regarding Cytotoxicity, Sensitivity and Irritation.
The MCL 31 Dermablate System passed all required testing and is in compliance with all applicable sections of the above-mentioned performance standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows 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.
April 13, 2022
Asclepion Laser Technologies GmbH Dania Paolo Regulatory Affairs Manager Bruesseler Strasse 10 Jena, Thuringia 07747 Germany
Re: K210634
Trade/Device Name: MCL 31 Dermablate 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: February 25, 2021 Received: March 3, 2021
Dear Dania Paolo:
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210634
Device Name MCL 31 Dermablate System
Indications for Use (Describe)
The MCL 31 Dermablate System with its accessories is indicated for coagulation, vaporization, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eves).
The MCL 31 Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the logo for Asclepion Laser Technologies. The logo features the word "Asclepion" in a gray, sans-serif font, with the words "Laser Technologies" in a smaller font size underneath. To the right of the text is a cluster of blue circles of varying sizes, arranged in a scattered pattern.
| Submitter: | ASCLEPION LASER TECHNOLOGIES GmbH
Bruesseler Str. 10
07747 Jena, Germany |
|----------------------|---------------------------------------------------------------------------------|
| Contact Person: | Tom Gruender
Regulatory Affairs Manager
ASCLEPION LASER TECHNOLOGIES GmbH |
| Phone: | +49 3641 77 00 201 |
| Fax: | +49 3641 77 00 302 |
| e-mail: | tom.gruender@asclepion.com |
| Preparation Date: | April 12, 2022 |
| Device Trade Name: | MCL 31 Dermablate System |
| Common Name: | Er:YAG laser |
| Classification Name: | Powered Laser Surgical Instrument |
| Regulation Number: | 21 CFR 878.4810 |
| Regulatory Class: | Class II |
| Product Code: | GEX |
| Submission Type: | Traditional 510(K) |
Legally Marketed Predicate Devices:
- . MCL 31 Dermablate (K150140) - Asclepion Laser Technologies
- . MicroSpot (K152153) - Asclepion Laser Technologies
Device Description:
The MCL 31 Dermablate System is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, detachable handpieces, and a footswitch. The MCL 31 Dermablate System can be operated with micro beam and non-micro beam handpieces. The system incorporates a suction unit for the safe removal of laser plume. The laser is fired with a foot-operated switch (footswitch).
Intended Use/Indications for Use:
The MCL 31 Dermablate System with its accessories is indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).
The MCL 31 Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
Summary of Technical Characteristics:
The MCL 31 Dermablate System that is the subject of this submission has identical technical characteristics as the previously cleared MCL 31 Dermablate System (K150140) and its MicroSpot handpiece (K152153).
The MY JULIET handpiece has similar technical characteristics, design, and functional features as the MicroSpot handpiece (K152153) for the MCL 31 Dermablate System, except for the differences shown
4
K210634 510(k) Summary
Image /page/4/Picture/1 description: The image shows the logo for Asclepion Laser Technologies. The logo features the word "Asclepion" in a gray, sans-serif font, with the words "Laser Technologies" in a smaller font below it. Above and to the right of the word "Asclepion" is a cluster of blue dots of varying sizes, arranged in a circular pattern.
in the table below. The minor differences in technical characteristics do not raise any new or different questions of safety or effectiveness.
Comparison with Predicate Devices:
The MCL 31 Dermablate System is substantially equivalent to the predicates with the same intended use and similar indications for use and technological characteristics including wavelength, spot size, and energy delivery.
| Specification | This Application | Predicate Devices | |
|---|---|---|---|
| Trade/Device Name | MCL 31 Dermablate | MCL 31 Dermablate | MicroSpot Handpiece |
| Submitter | Asclepion Laser | ||
| Technologies GmbH | Asclepion Laser | ||
| Technologies GmbH | Asclepion Laser | ||
| Technologies GmbH | |||
| 510(k) number | K210634 | K150140 | K152153 |
| Indications for use | The MCL 31 Dermablate System | ||
| with its accessories is indicated for | |||
| coagulation, vaporization, | |||
| ablation, or cutting of soft tissue | |||
| (skin) in Dermatology, Plastic | |||
| Surgery, Oral Surgery, ENT, | |||
| Gynecology, General Surgery, | |||
| Podiatry, and Ophthalmology (skin | |||
| around the eyes). | |||
| The MCL 31 Dermablate System, | |||
| when used with its micro beam | |||
| handpieces, is intended for use in | |||
| Dermatological procedures and | |||
| Skin resurfacing procedures. | Coagulation, | ||
| vaporization, ablation | |||
| or cutting of soft tissue | |||
| (skin) in Dermatology, | |||
| Plastic Surgery, Oral | |||
| Surgery, ENT, | |||
| Gynecology, General | |||
| Surgery, Podiatry and | |||
| Ophthalmology (skin | |||
| around the eyes) | The MicroSpot Handpiece | ||
| is intended for | |||
| Dermatological | |||
| procedures and Skin | |||
| resurfacing procedures. | |||
| Laser medium | Er:YAG | Er:YAG | Er:YAG |
| Wavelength | 2940 nm | 2940 nm | 2940 nm |
| Fluence, max. | VarioTEAM Handpiece: | ||
| 250 J/cm² | |||
| MicroSpot Handpiece: | |||
| 10 J/cm² (Up to 150 J/cm² | |||
| with stacking pulses) | |||
| MY JULIET Handpiece: | |||
| 5 J/cm² (Up to 35 J/cm² | |||
| with stacking pulses) | VarioTEAM Handpiece: | ||
| 250 J/cm² | MicroSpot Handpiece: | ||
| 10 J/cm² (Up to 150 J/cm² | |||
| with stacking pulses) | |||
| Energy, max | 2.5 J | ||
| 12 mJ/microbeam | |||
| (for MicroSpot Handpiece) | |||
| 7 mJ/microbeam (for My Juliet ) | 2.5 J | 12 mJ/microbeam | |
| Pulse Duration | 100 – 1000 μs | 100 – 1000 μs | 100 – 1000 μs |
| Repetition rate, max | 20 Hz | 20 Hz | 20 Hz |
| Treatment area / Spot size | VarioTEAM Handpiece: | ||
| 1 – 12 mm | |||
| MicroSpot Handpiece: | |||
| 350 μm - 600 µm spot, | |||
| MY JULIET Handpiece: | |||
| 425 μm & 600 µm spot, | VarioTEAM Handpiece: | ||
| 1 – 12 mm | MicroSpot Handpiece: | ||
| 350 μm - 600 µm spot, | |||
| WLAN module | No | Yes | Yes |
| Delivery system | Articulated Arm | Articulated Arm | Articulated Arm |
5
K210634 510(k) Summary
Image /page/5/Picture/1 description: The image shows the logo for Asclepion Laser Technologies. The logo features the word "Asclepion" in gray, with the words "Laser Technologies" in a smaller font size underneath. To the right of the text is a cluster of blue circles of varying sizes, arranged in a pattern that resembles a constellation or a stylized representation of laser beams.
Nonclinical Performance Data:
The following performance data were applied in support of the substantial equivalence determination:
- . EN 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- EN/IEC 60825-1: Safety of laser products - Part 1: Equipment classification, and requirements
- IEC 62304: Medical Device Software - Software life cycle processes
- ISO 14971: Medical devices - Applications of risk management to medical devices
Biocompatibility testing was also conducted for the MY JULIET handpiece in accordance with:
- EN/ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing ● within a risk management process
- ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytoxicity
- ISO 10993-10: Biological evaluation of medical devices - Part 10 Tests for irritation and skin sensitization
- . ISO 10993-23: Biological evaluation of medical devices - Part 23 Tests for irritation.
Software verification and validation testing was conducted, and documentation is provided in this submission, as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Biocompatibility: The biocompatibility of MCL 31 Dermablate System and compatible handpieces with the extended indications is established based on the legally marketed predicate devices. For the MY JULIET handpiece testing was conducted regarding Cytotoxicity, Sensitivity and Irritation.
The MCL 31 Dermablate System passed all required testing and is in compliance with all applicable sections of the above-mentioned performance standards.
Conclusion:
The MCL 31 Dermablate System has the same intended use and similar indications for use, technological characteristics, and principles of operation as the predicate devices. The minor differences in indications for use and technical characteristics do not raise different questions of safety or effectiveness. Thus, the MCL 31 Dermablate System is substantially equivalent to the predicate devices.