(134 days)
Not Found
No
The summary describes a laser system with standard components and performance testing against established safety and performance standards for medical lasers. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is described as a pulsed Er:YAG laser intended for medical procedures like coagulation, vaporization, ablation, or cutting of soft tissue, indicating its direct role in treating medical conditions.
No
The device is described as a pulsed Er:YAG laser intended for therapeutic purposes like coagulation, vaporization, ablation, and cutting of soft tissue. Its intended use is for surgical procedures to alter tissue, not to diagnose conditions.
No
The device description clearly outlines hardware components including a main console unit, handpiece, footswitch, and suction unit, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states the device is a laser system used for "Coagulation, vaporization, ablation or cutting of soft tissue (skin)". This is a direct surgical or therapeutic intervention performed on the patient's body.
- Intended Use/Indications: The listed applications (Dermatology, Plastic Surgery, etc.) involve treating or altering tissue directly, not analyzing samples.
The device is a therapeutic laser system, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
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).
Product codes
GEX
Device Description
The MCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. The MCL 31 is operated with a handpiece of larger spotsize. The system incorporates a suction unit for the safe removal of laser plume.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Nonclinical Performance Data: The MCL 31 Dermablate laser system is tested according to following standards: ISO 14971:2009, DIN EN 60601-1:2006, DIN EN 60601-1-2:2007, DIN EN 60601-1-6:2007, DIN EN 60601-2-22:1996, DIN EN 60825-1:2007, DIN EN 62304:2006.
Clinical Performance Data: None
Key Metrics
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
Asclepion Laser Technologies GmbH Ms. Antje Katzer Regulatory Affairs Manager Bruesseler Straße 10 07747 Jena, Thuringia Germany
Re: K150140 Trade/Device Name: MCL 31 Dermablate 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: May 5, 2015 Received: May 8, 2015
Dear Ms. Katzer:
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. 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 requirements, including, but not limited to: registration and listing (21
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150140
Device Name
MCL 31 Dermablate
Indications for Use (Describe)
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).
| 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
== -
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Asclepion Laser Technologies GmbH • Brüsseler Str. 10 • 07747 Jena • Germany
Traditional 510(k) SUMMARY
MCL 31 Dermablate
This Traditional 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MCL 31 Dermablate is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbH
Bruesseler Str. 10
07747 Jena, Germany |
|---------------------------|---------------------------------------------------------------------------------|
| Contact Person: | Mrs. Antje Katzer
Product Management and
International Regulatory Affairs |
| Phone:
Fax:
e-mail: | +49 3641 77 00 309
+49 3641 77 00 302
antje.katzer@asclepion.com |
| Preparation Date: | June 3, 2015 |
| Device Name: | MCL 31 Dermablate |
| Common Name: | Er:YAG Laser |
Our general terms and conditions: www.asclepion.com
Registered office: Jena Register of commerce court: Jena HRB 209648 UST ID Nr. DE 813678553 WEEE-Reg.-Nr. DE 33663120 Managing Director: Dr. Danilo Leggieri
Bank Connections: Sparkasse Jena • SWIFT HELADEF1JEN • IBAN DE 348305303000000000094 Deutsche Bank Jena • SWIFT DEUTDE8EXXX • IBAN DE 67820700000397755000 Commerzbank Jena • SWIFT COBADEFF821 • IBAN DE 54820400000258272400
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| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in
dermatology
79-GEX
21 CFR 878.4810
Regulatory Class: Class II
Product Codes: GEX |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalent Devices: | K081541 Dermablate Effect (Asclepion Laser Technologies)
K101306 Fotona Dynamis Er:YAG Laser System (Fotona) |
| Device Description: | The MCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of
2940 nm. The system comprises a main console unit, a handpiece and is
triggered by means of a footswitch. The MCL 31 is operated with a
handpiece of larger spotsize. The system incorporates a suction unit for the
safe removal of laser plume. |
| Intended Use: | The MCL 31 Dermablate laser system is intended for coagulation,
vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plasti
Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and
Ophthalmology (skin around the eyes). |
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Summary of Technical Characteristics
| Proposed Modified Device | Un-Modified Predicate Device | Un-Modified Predicate Device | |
|---|---|---|---|
| Name | MCL 31 Dermablate | Dermablate Effect with | Dynamis Er:YAG Laser |
| Manufacturer | Asclepion Laser Technologies | Handpiece of larger spot size | |
| Asclepion Laser Technologies | Fotona | ||
| 510(k) | K081541 | K101306 | |
| Intended Use | |||
| (handpiece with larger | |||
| spot size) | 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). | Coagulation, vaporization, ablation | ||
| or cutting of soft tissue (skin) in | |||
| dermatology, plastic surgery, oral | |||
| surgery and ophthalmology (skin | |||
| around the eyes). | Surgical incision/excision, | ||
| vaporization and coagulation of soft | |||
| tissue during any general surgery | |||
| application where skin incision, tissue | |||
| dissection, excision of lesions, | |||
| complete or partial resection of | |||
| internal organs, lesions, tissue | |||
| ablation and vessel coagulation is | |||
| necessary. | |||
| Dermatology and Plastic Surgery, | |||
| ENT Surgery, Oral/Maxillofacial | |||
| Indications, Ophthalmology, | |||
| Gynecology, General Surgery, | |||
| Podiatry. | |||
| Laser medium | |||
| wavelength | Er:YAG | ||
| 2940 nm | Er:YAG | ||
| 2940 nm | Er:YAG | ||
| 2940 nm | |||
| Principle of interaction | |||
| with skin | Ablation, Coagulation | Ablation, Coagulation | Ablation, Coagulation |
| Energy, max. | $2,5 J$ | $1,5 J$ | $3,0 J$ |
| Power, max. | $20 W$ | $12 W$ | $20 W$ |
| Frequency, max. | $20 Hz$ | $20 Hz$ | $50 Hz$ |
| Spot size | $1-12 mm$ | $1-6 mm$ | $0,3-12 mm$ |
| Fluence, max. | $250 J/cm^2$ | $100 J/cm^2$ | $250 J/cm^2$ |
| Pulsewidth | $100 - 1000 μs$ | $350 μs$ | $100 - 1500 μs$ |
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| Comparison to: | The MCL 31 Dermablate laser system is substantially equivalent to the Dermablate Effect K081541 and the Fotona Dynamis Er:YAG laser K101306, with the same principles of operation, with similar parameter and the same indications for use. The fundamental scientific technology of the device is unchanged from the legally marketed predicates. |
|---|---|
| Nonclinical Performance Data: | The MCL 31 Dermablate laser system is tested according to following standards: |
| ISO 14971:2009 | |
| DIN EN 60601-1:2006 | |
| DIN EN 60601-1-2:2007 | |
| DIN EN 60601-1-6:2007 | |
| DIN EN 60601-2-22:1996 | |
| DIN EN 60825-1:2007 | |
| DIN EN 62304:2006 | |
| Clinical Performance Data: | None |
| Conclusion: | The MCL 31 Dermablate laser system is another safe and effective device 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).