TATTOOSTAR FAMILY

K060787 · Asclepion Laser Technologies GmbH · GEX · Sep 27, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060787
• Device Name: TATTOOSTAR FAMILY
• Applicant: Asclepion Laser Technologies GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 27, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TattooStar R is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion. Some examples of pigment lesions are: Lentigines, Café-au-lait-blotches, Ephalides, BenignNaevi such as Naevus of Ota, Naevus of Ito, Epidermal Naevi, Congenital Naevi, Beckers Naevi, Blue Nevus, Naevus Spillus and Mongolian Spot.

Device Story

TattooStar R is a Q-switched solid-state laser emitting 694 nm (ruby) wavelength. Device comprises laser enclosure and articulated mirror arm for optical delivery. Used in clinical dermatology settings by physicians for soft tissue ablation, vaporization, cutting, and removal of tattoos or benign pigmented lesions. Principle of operation relies on laser-tissue interaction at 694 nm. Output is controlled laser energy; provider directs beam to target tissue. Benefits include precise tissue removal and pigment clearance. Device lacks long-pulsed mode found in predicate.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Q-switched solid-state laser; 694 nm wavelength; articulated mirror arm delivery system. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for cutting, vaporization, and ablation of soft tissue, tattoo removal, and treatment of benign pigmented lesions (e.g., lentigines, café-au-lait, naevi) in patients requiring dermatological laser surgery.

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

• RubyStar

Submission Summary (Full Text)

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K060787

SEP 2 7 2006

## 510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH TattooStar family

This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH TattooStar family 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>Am Semmicht 1A<br>07755 Jena, Germany |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr Reinhard Thieme<br>Quality Assurance and<br>International Regulatory Affairs |
| Phone:<br>Fax:<br>e-mail: | [phone]<br>[phone]<br>[e-mail] |
| Preparation Date: | June 18th, 2006 |
| Device Name: | TattooStar R |
| Common Name: | TattooStar R |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.481 |
| Equivalent Device: | RubyStar |
| Device Description: | The TattooStar R is a q-switched solid state lasers emitting<br>wavelengths of 694 nm (Rubylaser). It consists a laser<br>enclosure and optic delivery system (articulated mirror arm). |
| Intended Use: | The TattooStar R is indicated of cutting, vaporization or<br>ablation of soft tissue. This includes tattoo removal and<br>treatment of benign pigmented lesions. |
| Comparison to: | The TattooStar R is substantially equivalent to the RubyStar,<br>with the same principles of operation, and the same<br>indication for use ,the same wavelength but without a long<br>pulsed mode which is used for hair removal. |

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K060727

Nonclinical Performance Data: None Clinical Performance Data: None Conclusion: The TattooStar R is another safe and effective device for the removal of tattoos and pigmented lesions and for ablation, cutting, vaporization of soft tissue for general dermatology. None

Additional Information :

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a human figure embracing a globe.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Asclepion Laser Technologies GmbH % Reinhard Thieme Quality Assurance Manager Arn Semmicht 1 A 07755 Jena. Germany

SEP 2 7 2006

Re: K060787

Trade/Device Name: TattooStar R 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 Dated: August 24, 2006 Received: August 28, 2006

Dear Reinhard Thieme:

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 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.

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## Page 2 - Reinhard Thieme

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

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 (if known): K060787

Device Name: TattooStar R

Indications for Use:

The TattooStar R is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.

Some examples of pigment lesions are:

Lentigines, Café-au-lait-blotches, Ephalides, BenignNaevi such as Naevus of Ota, Naevus of Ito, Epidermal Naevi, Congenital Naevi, Beckers Naevi, Blue Nevus, Naevus Spillus and Mongolian Spot.

Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number. K060787