DERMABLATE EFFECT

K081541 · Asclepion Laser Technologies GmbH · GEX · Feb 23, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K081541
• Device Name: DERMABLATE EFFECT
• Applicant: Asclepion Laser Technologies GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dermablate Effect Er:YAG laser with handpiece of larger spot sizes is intended for use for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery, oral surgery and ophthalmology (skin around the eyes). The Dermablate Effect Er:YAG laser with fractional handpiece is intended for dermatological and skin resurfacing procedures. The Dermablate Effect can be equipped optionally with the following modules: Asclepion Pulsed Light (APL) and Acoustic Wave (AW). The Asclepion Pulsed Light is intended for permanent hair reduction, treatment of vascular and pigmented lesions and inflammatory acne. The Acoustic Wave is intended for the activation of connective tissue.

Device Story

Dermablate Effect is a multi-modal system combining a 2940 nm pulsed Er:YAG laser with optional Asclepion Pulsed Light (APL) and Acoustic Wave (AW) modules. Laser module uses various handpieces (large spot or fractional) for soft tissue surgery and skin resurfacing. APL module targets hair, vascular/pigmented lesions, and acne. AW module provides acoustic stimulation for connective tissue. Operated by clinicians in dermatology, plastic surgery, oral surgery, and ophthalmology settings. Device transforms electrical energy into laser, light, or acoustic outputs. Clinicians use these outputs to perform procedures; clinical decision-making relies on provider assessment of patient skin condition and treatment goals. Benefits include precise tissue management and aesthetic skin improvement.

Clinical Evidence

Clinical evidence includes a histological report by Prof. D. Cassuto regarding fractional Er:YAG procedures. No other clinical performance data provided. The device is deemed safe and effective based on its equivalence to legally marketed predicates.

Technological Characteristics

Multi-modal system: 2940 nm pulsed Er:YAG laser, optional APL module, and optional AW module. Features interchangeable handpieces for large spot or fractional delivery. System is intended for professional clinical use. Biocompatibility testing performed on all handpieces.

Indications for Use

Indicated for soft tissue (skin) coagulation, vaporization, ablation, or cutting in dermatology, plastic surgery, oral surgery, and ophthalmology (periocular skin); dermatological skin resurfacing; permanent hair reduction; treatment of vascular/pigmented lesions and inflammatory acne; and activation of connective tissue.

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

• MCL 30 Dermablate
• Lux2940 Erbium Fractional Handpiece
• Profile ProFractional Handpiece
• Photosilk Plus
• Cellactor SC1
• D-Actor Vibration Massage System

Reference Devices

• D-Actor 200 Vibration Massage System

Submission Summary (Full Text)

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K 081541

## 510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH Dermablate Effect

FEB 2 3 2009

This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies -GmbH Dermablate Effect 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: | February 13th, 2009 |
| Device Name: | Dermablate Effect |
| Common Name: | Dermablate Effect |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.481 |
| Equivalent Devices: | MCL 30 Dermablate<br>Lux2940 Erbium Fractional Handpiece<br>Profile ProFractional Handpiece<br>Photosilk Plus<br>Cellactor SC1<br>D-Actor Vibration Massage System |
| Device Description: | The Dermablate Effect is a pulsed Er:YAG laser emitting a<br>wavelength of 2940 nm, that can optionally be equipped<br>with a pulsed light module (APL) and an acoustic wave<br>module (AW). |

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| Intended Use: | The Dermablate Effect Er:YAG laser with handpiece of larger<br>spot sizes is intended for use for coagulation, vaporization,<br>ablation or cutting of soft tissue (skin) in dermatology,<br>plastic surgery, oral surgery and ophthalmology (skin<br>around the eyes).<br><br>The Dermablate Effect Er:YAG laser with fractional<br>handpiece is intended for dermatological and skin<br>resurfacing procedures.<br><br>The Dermablate Effect can be equipped optionally with the<br>following modules: Asclepion Pulsed Light (APL) and<br>Acoustic Wave (AW).<br><br>The Asclepion Pulsed Light is intended for permanent hair<br>reduction, treatment of vascular and pigmented lesions and<br>inflammatory acne.<br><br>The Acoustic Wave is intended for the activation of<br>connective tissue. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to: | The Dermablate Effect is substantially equivalent to the<br>MCL 30 Dermablate (with regard to the Er:YAG laser<br>module with handpiece of larger spotsizes), to the Lux2940<br>Erbium Fractional Handpiece and the Profile ProFractional<br>Handpiece (with regard to the Er:YAG laser module with<br>fractional handpiece) to the Photosilk Plus (with regard to<br>the APL module) and to the class 1 products Cellactor SC1<br>and D-Actor 200 (with regard to the AW module) with the<br>same principles of operation, and the same indications for use. |
| Nonclinical Performance Data: | None |

Clinical Performance Data: Fractional Er:YAG histological report of Prof. D. Cassuto

The Dermablate Effect is another safe and effective device Conclusion: for coagulation, vaporization, ablation, cutting of soft tissue, for fractional dermatological and skin resurfacing procedures, for permanent hair reduction, the treatment of vascular and pigmented lesions and inflammatory acne and for the activation of connective tissue.

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Additional Information :

## Software Description

Tables of comparison and 510(k) summaries for D-Actor 200 Vibration Massage System, Lux2940 Erbium Fractional Handpiece, Profile ProFractional Handpiece

Fractional Er:YAG histological report of Prof. D. Cassuto

Biocompatibility test reports for all handpieces

Professional User Guide with treatment parameters for different applications in all modules

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Asclepion Laser Technologies GmbH % Mrs. Antie Katzer Product Management and International Regulatory Affairs Bruesseler Str. 10 07747 Jena, Germany

Re: K081541

Trade/Device Name: Dermablate Effect Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, ISA

FEB 2 3 2009

Dated: February 16, 2009 Received: February 18, 2009

### 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mrs. Antje Katzer

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

510(k) Number: K081541

Device Name: Dermablate Effect

Indications for Use:

The Dermablate Effect Er:YAG laser with handpiece of larger spot sizes is intended for use for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery, oral surgery and ophthalmology (skin around the eyes).

The Dermablate Effect Er:YAG laser with fractional handpiece is intended for dermatological and skin resurfacing procedures.

The Dermablate Effect can be equipped optionally with the following modules: Asclepion Pulsed Light (APL) and Acoustic Wave (AW).

The Asclepion Pulsed Light is intended for permanent hair reduction, treatment of vascular and pigmented lesions and inflammatory acne.

The Acoustic Wave is intended for the activation of connective tissue.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter
(21 CFR 801 S

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K081541