TATTOOSTAR EFFECT Y

K112669 · Asclepion Laser Technologies GmbH · GEX · May 11, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K112669
• Device Name: TATTOOSTAR EFFECT Y
• Applicant: Asclepion Laser Technologies GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TattooStar Effect Y laser is indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and unwanted hair and skin resurfacing procedures. For the specific wavelengths of the TattooStar Effect Y the indications are as follows: 532 nm: Removal of pigmented lesions (including but not limited to lentigo benigna, hyperpigmented burn and boil scar, naevus Ota / Ito, freckles, Becker naevi, Café-au-lait spots) removal of red tattoo inks removal of minor vascular lesions 1064 nm: removal of black and dark blue tattoo inks removal of unwanted hair skin resurfacing 585 nm: removal of sky blue tattoo inks The Asclepion Pulsed Light of the TattooStar Effect Y is intended for permanent hair reduction, treatment of vascular lesions, pigmented lesions and inflammatory acne. Depending on the different filters, the indications are as follows: 400 - 750 nm: Acne 500 - 1200 nm: Hair removal of blond hair, skin type I-II Vascular lesions, skin type I-II 550 - 1200 nm: Hair removal of brown and black hair, skin type I-II Hair removal of blond, brown and black hair, skin type III Vascular lesions, skin type III-IV Pigmented lesions, skin type I-IV 650 - 1200 nm: Hair removal of black hair, skin type IV The Radiofrequency of the TattooStar Effect Y is intended for dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids. The Acoustic Wave of the TattooStar Effect Y is intended for the activation of connective tissue.

Device Story

Multi-modal dermatological system; combines pulsed Nd:YAG laser (1064nm, 532nm, optional 585nm dye handpiece) with optional Pulsed Light (APL), Radiofrequency (RF), and Acoustic Wave (AW) modules. Laser targets tissue via photothermolysis for tattoo removal, hair reduction, and resurfacing. APL uses specific spectral filters for acne, vascular/pigmented lesions, and hair removal. RF provides non-invasive wrinkle treatment; AW activates connective tissue. Operated by clinicians in dermatology/surgical settings. Output consists of controlled energy delivery to skin/tissue. Clinical benefit includes aesthetic improvement and lesion resolution. Device relies on modular attachments to expand treatment capabilities beyond standard laser surgery.

Clinical Evidence

No clinical data provided for the laser, APL, or AW modules. Clinical evidence limited to an in vivo study for the removal of wrinkles using the Radiofrequency module.

Technological Characteristics

Pulsed Nd:YAG solid-state laser; wavelengths 1064nm, 532nm, 585nm (dye). Modular architecture: APL (pulsed light), RF (radiofrequency), and AW (acoustic wave) modules. Energy delivery via handpieces. System is a floor-standing laser surgical instrument.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, ablation, vaporization, tattoo removal, pigmented/vascular lesion treatment, hair reduction, skin resurfacing, acne treatment, or wrinkle reduction. Specific indications vary by wavelength (532/1064/585nm) and APL filter (400-1200nm range) based on skin type (I-IV) and hair/lesion characteristics.

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

• Spectra (K071451, K103455)
• TattooStar Y (K081541)
• Dermablate Effect (K051214)
• Aluma (K052688)
• Ellipse Flex PPT (K052688)

Submission Summary (Full Text)

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K112669

MAY 1 1 2012

# 510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH TattooStar Effect Y

This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH TattooStar Effect Y 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

[e-mail]

[phone]

[phone]

TattooStar Effect Y

TattooStar Effect Y

May 2nd , 2012

Phone: Fax: e-mail:

Preparation Date:

Device Name:

Common Name:

Classification Name:

Laser surgical instrument for use in general and plastic surgery and in dermatology 79-GEX 21 CFR 878.4810

TattooStar Y Equivalent Devices: Spectra

K071451 K103455 Dermablate Effect K081541 K051214 Aluma Ellipse Flex PPT K052688

Device Description:

The TattooStar Effect Y is a pulsed Nd:YAG solid state laser emitting wavelengths of 1064nm and 532nm. The beam can be converted to 585nm by means of an optional dye handpiece. The laser system can optionally be equipped with a pulsed light module (APL), a radiofrequency module (RF) and an acoustic wave module (AW).

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Intended Use:

The TattooStar Effect Y laser is indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and unwanted hair and skin resurfacing procedures. For the specific wavelengths of the TattooStar Effect Y the indications are as follows:

532 nm: Removal of pigmented lesions (including but not limited to lentigo benigna, hyperpigmented burn and boil scar, naevus Ota / Ito, freckles, Becker naevi, Café-au-lait spots) removal of red tattoo inks removal of minor vascular lesions 1064 nm: removal of black and dark blue tattoo inks removal of unwanted hair skin resurfacing 585 nm: removal of sky blue tattoo inks

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

Depending on the different filters, the indications are as follows:

| 400 - 750 nm: | Acne |
|----------------|---------------------------------------------------------------|
| 500 - 1200 nm: | Hair removal of blond hair, skin type I-II |
| | Vascular lesions, skin type I-II |
| 550 - 1200 nm: | Hair removal of brown and black hair, skin<br>type I-II |
| | Hair removal of blond, brown and black hair,<br>skin type III |
| | Vascular lesions, skin type III-IV |
| | Pigmented lesions, skin type I-IV |
| 650 - 1200 nm: | Hair removal of black hair, skin type IV |

The Radiofrequency of the TattooStar Effect Y is intended for dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids.

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

Comparison to:

The TattooStar Effect Y is substantially equivalent to the Spectra Laser system and to the TattooStar Y with the same principles of operation, with similar parameters and the with the same indications for use regarding the laser system. The TattooStar Effect Y is substantially equivalent to the Dermablate Effect with regard to the APL module and the AW module with nearly the same parameters and the same intended use. The APL module of the TattooStar Effect Y is also substancially equivalent to the Ellipse Flex PPT with similar specifications and almost the same intended use. The TattooStar Effect Y is substancially equivalent to the Aluma system with regard to the RF module with similar

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## parameters and the same intended use.

Nonclinical Performance Data: None

Clinical Performance Data:

In vivo study for the removal of wrinkles by means of Radiofrequency.

Conclusion:

The TattooStar Effect Y is another safe and effective device for the incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and unwanted hair and skin resurfacing procedures.

When equipped with optional modules, the TattooStar Effect Y is a safe and effective device for permanent hair reduction, treatment of vascular and pigmented lesions and inflammatory acne, for dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids and for the activation of connective tissue.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# ASCLEPION LASER TECHNOLOGIE GmbH

% Ms. Antje Katzer Product Management and International Regulatory Affairs Bruesseler Str. 10 07747 Jeana Germany

MAY 1 1 2012

#### Re: K112669

Trade/Device Name: TattooStar Effect Y 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 4, 2012 Received: May 9, 2012

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 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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# Page 2 - Ms. 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

#### 510(k) Number: K112669

Device Name:

#### TattooStar Effect Y

Indications for Use:

The TattooStar Effect Y laser is indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and unwanted hair and skin resurfacing procedures.

Depending on the wavelength selected, the indications are as follows:

Removal of black and blue tattoo color 1064 nm: .

Removal of unwanted hair

Skin resurfacing

532 nm:

Removal of pigmented lesions (including but not limited to lentigo benigna, hyperpigmented burn and boil scar, naevus Ota / Ito, freckles, Becker naevi, Café-au-lait spots) Removal of red tattoo color

Removal of minor vascular lesions

Removal of sky blue tattoo color 585 nm:

The Asclepion Pulsed Light of the TattooStar Effect Y is intended for permanent hair reduction, treatment of vascular lesions, pigmented lesions and inflammatory acne. Depending on the different filters, the indications are as follows:

| 400 - 750 nm: | Acne |
|----------------|------------------------------------------------------------|
| 500 - 1200 nm: | Hair removal of blond hair, skin type I-II |
| | Vascular lesions, skin type I-II |
| 550 - 1200 nm: | Hair removal of brown and black hair, skin type I-II |
| | Hair removal of blond, brown and black hair, skin type III |
| | Vascular lesions, skin type III-IV |
| | Pigmented lesions, skin type I-IV |
| 650 - 1200 nm: | Hair removal of black hair, skin type IV |

The Radiofrequency is intended for dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids.

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

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) | |

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

> (Division Sign-Off) (Division of Surgical, Orthopedic,

Concurrence of CDRH, Office of Device Evaluation Respeative Devices

510(k) Number K112