MicroSpot Handpiece

K152153 · Asclepion Laser Technologies GmbH · GEX · Dec 11, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K152153
• Device Name: MicroSpot Handpiece
• Applicant: Asclepion Laser Technologies GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroSpot handpiece is intended for Dermatological procedures and Skin resurfacing procedures.

Device Story

The MicroSpot Handpiece is an accessory for the MCL 31 Dermablate Er:YAG laser system (2940 nm). It utilizes a microlens array to transform the laser output into a microbeam pattern for skin resurfacing. The device is operated by a clinician in a clinical setting; the system is triggered via footswitch and includes an integrated suction unit for laser plume removal. The clinician uses the handpiece to deliver fractionated laser energy to the skin, creating micro-ablation zones. This process facilitates skin resurfacing and dermatological treatment by inducing controlled thermal damage and subsequent healing. The device benefits patients by providing a method for skin rejuvenation and dermatological correction.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing and an in vivo animal study. Animal study used nine pigs treated with varying energy levels (20, 40, 60 J/cm²) and pulse durations. Histological samples collected at days 0, 3, and 14 demonstrated ablation depth, thermal damage zones, and healing response, supporting the safety and effectiveness of the microbeam mode.

Technological Characteristics

Er:YAG laser (2940 nm) with microlens array for microbeam creation. Max energy 2.5 J, max power 20 W, max frequency 20 Hz. Spot sizes 350 and 600 µm. Coverage 10-25%. Standards: ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, IEC 62304.

Indications for Use

Indicated for dermatological and skin resurfacing procedures. No specific patient population, age, or gender restrictions are provided.

Regulatory Classification

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.

Predicate Devices

• Dermablate Effect (K081541)
• Fotona Dynamis Er:YAG Laser System (K101306)
• Fotona FS-01 Laser Handpiece (K132806)

Reference Devices

• MCL 31 Dermablate (K150140)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>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) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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| 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<br>Bruesseler Str. 10<br>07747 Jena, Germany |
|---------------------------|---------------------------------------------------------------------------------|
| Contact Person: | Mrs. Antje Katzer<br>Product Management and<br>International Regulatory Affairs |
| Phone:<br>Fax:<br>e-mail: | [phone]<br>[phone]<br>[e-mail] |
| 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<br>dermatology<br>79-GEX<br>21 CFR 878.4810<br>Regulatory Class: Class II<br>Product Code: GEX |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalent Devices: | K081541 Dermablate Effect (Asclepion Laser Technologies)<br>K101306 Fotona Dynamis Er:YAG Laser System (Fotona)<br>K132806 Fotona FS-01 Laser Handpiece (Fotona) |
| Device Description: | The MicroSpot Handpiece is a handpiece with microbeam output to be<br>used with the previously cleared MCL 31 Dermablate (K150140). The<br>MCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of<br>2940 nm. The system comprises a main console unit, a handpiece and<br>is triggered by means of a footswitch. The MCL 31 can be operated<br>with a handpiece of larger spotsize or with a microbeam handpiece.<br>The system incorporates a suction unit for the safe removal of laser<br>plume. |
| Intended Use: | The MicroSpot handpiece is intended for Dermatological procedures<br>and Skin resurfacing procedures. |

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## Summary of Technical Characteristics

| | Proposed Modified Device | Un-Modified Predicate Device | Un-Modified Predicate Device |
|---------------------------------------|------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Name | MCL 31 Dermablate with MicroSpot<br>Zoom Handpiece | Dermablate Effect with<br>MicroSpot - Zoom handpiece | Dynamis Er:YAG Laser System<br>Family with<br>FS 01-Handpiece<br>Fotona |
| Manufacturer | Asclepion Laser Technologies | Asclepion Laser Technologies | Fotona |
| 510(k) | | K081541 | K101306 / K132806 |
| Intended Use<br>(Microbeam handpiece) | Dermatological procedures.<br>Skin resurfacing procedures. | Dermatological procedures.<br>Skin resurfacing procedures. | Dermatological procedures requiring<br>resurfacing of soft tissue with<br>fractionated handpiece. |
| Laser medium<br>wavelength | Er:YAG<br>2940 nm | Er:YAG<br>2940 nm | Er :YAG<br>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<br>Up to 150 J/cm² with stacking<br>pulses | 18 J/cm²<br>Up to 162 J/cm² with stacking pulses | Up to 800 J/cm² with stacking pulses |
| Max. Energy per<br>Microbeam | 12 mJ | 8 mJ | 160 mJ |
| Pulse Duration | 0,1 - 1,0 ms | < 1 ms | 0,1 - 1,5 ms |
| Pulse repetition rate | Up to 20 Hz | Up to 20 Hz | Up to 50 Hz |
| Spot size of microbeams | 350 and 600 µm | 250 µm | 250 µm |
| Creation of microbeams | By microlens array | By microlens array | By microlens array |
| Treatment zones | 13 x 13 mm | 13 x 13 mm<br>9 x 9 mm<br>7 x 7 mm | 13 x 13 mm |
| Coverage of skin | 10 and 25 % | 5 - 17 % | 5 - 60 % |

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Comparison to: The MicroSpot Handpiece of the MCL 31 Dermablate laser system is substantially equivalent to the MicroSpot Handpiece of the Dermablate Effect K081541 and the Fotona FS-01 Laser Handpiece K132806 of the Fotona Dynamis Er:YAG laser K101306 with the same principles of operation, with similar parameters and with similar indications for use. The fundamental scientific technology of the device is unchanged from the legally marketed predicates.

Nonclinical Performance Data: The MicroSpot Handpiece is designed and tested according to following standards:

> 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.