(130 days)
No
The summary describes a laser handpiece and its use with a previously cleared laser system. There is no mention of AI, ML, image processing, or any data-driven algorithms in the device description, intended use, or performance studies. The performance studies focus on physical characteristics of the laser and its effect on tissue.
Yes
The device is intended for dermatological procedures and skin resurfacing, which are medical treatments for conditions affecting the skin.
No
The device is described as "intended for Dermatological procedures and Skin resurfacing procedures" and involves a laser for tissue ablation, which indicates a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is a "handpiece with microbeam output" and is used with a laser system, indicating it is a hardware component, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Dermatological procedures and Skin resurfacing procedures." This describes a direct treatment applied to the patient's skin, not a test performed on a sample taken from the body.
- Device Description: The device is a laser handpiece used with a laser system. It applies laser energy to the skin.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of substances in samples
- Diagnosis or monitoring of a disease based on sample analysis
This device is a therapeutic device used for medical procedures on the patient's body.
N/A
Intended Use / Indications for Use
The MicroSpot Handpiece is intended for Dermatological procedures and Skin resurfacing procedures.
Product codes
GEX
Device Description
The MicroSpot Handpiece is a handpiece with microbeam output to be used with the previously cleared MCL 31 Dermablate (K150140). 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 can be operated with a handpiece of larger spotsize or with a microbeam handpiece. 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
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: Laboratory testing was conducted to validate and verify that the MicroSpot Handpiece met all design specifications and was substantially equivalent to the predicate devices. The size of the single microspots was evaluated as well as the laser pulse duration, the energy release of the laser and the energy in a duration test. The results of those testings were used to select the desired parameters with the MicroSpot handpiece.
Animal Performance Data: Histological data was submitted to support safety and effectiveness of the microbeam mode. The device was used in vivo on pig skin with low, medium and high energies, and with different pulse durations and densities. The five possible settings of the handpiece were applied to nine pigs. Three received 20 J/cm², three received 40 J/cm² and three received 60 J/cm². The histological samples have been collected at day 0, 3 and 14. The biopsied areas show the depth and width of ablation as well as the thermal damage zones and demonstrate the healing response over time.
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 the logo for the U.S. Department of Health and Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around a central emblem. The emblem consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare, with three human profiles incorporated into the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Asclepion Laser Technologies GmbH Mrs. Antje Katzer Product Management and International Regulatory Affairs Bruesseler Str.10, Jena, Thuringia 07747 Germanv
December 11, 2015
Re: K152153 Trade/Device Name: MicroSpot Handpiece 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: November 13, 2015 Received: November 13, 2015
Dear Mrs. 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 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
1
forth in the quality systems (QS) 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.
Sincerelv vours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director
For
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K152153 |
|---|---|
| Device Name | MicroSpot Handpiece |
| Indications for Use (Describe) | The MicroSpot Handpiece is intended for Dermatological procedures and Skin resurfacing procedures. |
| 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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Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"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."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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Image /page/3/Picture/0 description: The image shows the logo for Asclepion Laser Technologies. The word "Asclepion" is written in a dark gray sans-serif font. To the right of the word "Asclepion" are several blue circles of varying sizes, arranged in a semi-circular pattern. Below the word "Asclepion" is the phrase "Laser Technologies" in a smaller, lighter gray font.
Asclepion Laser Technologies GmbH · Brüsseler Str. 10 · 07747 Jena · Germany
Traditional 510(k) SUMMARY
MicroSpot Handpiece
This Traditional 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MicroSpot Handpiece 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: | December 10, 2015 |
| Device Name: | MicroSpot Handpiece |
| Common Name: | Microbeam Handpiece for 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. Dr. Danilo Leggieri Bank Connections: Sparkasse Jena • SWIFT HELADEF1JEN • IBAN DE 3483053030000000094 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 Code: GEX |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalent Devices: | K081541 Dermablate Effect (Asclepion Laser Technologies)
K101306 Fotona Dynamis Er:YAG Laser System (Fotona)
K132806 Fotona FS-01 Laser Handpiece (Fotona) |
| Device Description: | The MicroSpot Handpiece is a handpiece with microbeam output to be
used with the previously cleared MCL 31 Dermablate (K150140). 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 can be operated
with a handpiece of larger spotsize or with a microbeam handpiece.
The system incorporates a suction unit for the safe removal of laser
plume. |
| Intended Use: | The MicroSpot handpiece is intended for Dermatological procedures
and Skin resurfacing procedures. |
5
Summary of Technical Characteristics
| Proposed Modified Device | Un-Modified Predicate Device | Un-Modified Predicate Device | |
|---|---|---|---|
| Name | MCL 31 Dermablate with MicroSpot | ||
| Zoom Handpiece | Dermablate Effect with | ||
| MicroSpot - Zoom handpiece | Dynamis Er:YAG Laser System | ||
| Family with | |||
| FS 01-Handpiece | |||
| Fotona | |||
| Manufacturer | Asclepion Laser Technologies | Asclepion Laser Technologies | Fotona |
| 510(k) | K081541 | K101306 / K132806 | |
| Intended Use | |||
| (Microbeam handpiece) | Dermatological procedures. | ||
| Skin resurfacing procedures. | Dermatological procedures. | ||
| Skin resurfacing procedures. | Dermatological procedures requiring | ||
| resurfacing of soft tissue with | |||
| fractionated handpiece. | |||
| Laser medium | |||
| wavelength | Er:YAG | ||
| 2940 nm | Er:YAG | ||
| 2940 nm | Er :YAG | ||
| 2940 nm | |||
| 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 |
| Fluence, max. | 10 J/cm² | ||
| Up to 150 J/cm² with stacking | |||
| pulses | 18 J/cm² | ||
| Up to 162 J/cm² with stacking pulses | Up to 800 J/cm² with stacking pulses | ||
| Max. Energy per | |||
| Microbeam | 12 mJ | 8 mJ | 160 mJ |
| Pulse Duration | 0,1 - 1,0 ms | ISO 14971:2009 IEC 60601-1:2005 IEC 60601-1-2:2007 IEC 60601-1-6:2010 IEC 60601-2-22:2007 IEC 60825-1:2007 IEC 62304:2006 |
Laboratory testing was conducted to validate and verify that the MicroSpot Handpiece met all design specifications and was substantially equivalent to the predicate devices.
The size of the single microspots was evaluated as well as the laser pulse duration, the energy release of the laser and the energy in a duration test.
The results of those testings were used to select the desired parameters with the MicroSpot handpiece.
Animal Performance Data: Histological data was submitted to support safety and effectiveness of the microbeam mode. The device was used in vivo on pig skin with low, medium and high energies, and with different pulse durations and densities. The five possible settings of the handpiece were applied to nine pigs. Three received 20 J/cm², three received 40 J/cm² and three received 60 J/cm². The histological samples have been collected at day 0, 3 and 14. The biopsied areas show the depth and width of ablation as well as the thermal damage zones and demonstrate the healing response over time. Conclusion: The MicroSpot Handpiece is another safe and effective device for Dermatological and Skin resurfacing procedures.