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.

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).

AI/ML Overview

The provided 510(k) summary for the Asclepion Laser Technologies GmbH TattooStar Effect Y does not contain typical acceptance criteria tables or detailed study results for device performance as would be found in a clinical trial report.

Instead, the submission primarily focuses on establishing "substantial equivalence" to predicate devices, which is common for 510(k) clearances. This means the manufacturer largely relies on the safety and effectiveness of previously cleared devices with similar technology and intended uses, rather than conducting extensive new clinical studies with defined acceptance criteria for the new device.

Here's an analysis based on the information provided, highlighting what is present and what is absent from the request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of quantitative metrics (e.g., specific percentages of lesion clearance, wrinkle reduction metrics, etc.)	The device is deemed "safe and effective" for its stated indications based on substantial equivalence to predicate devices.
	For Radiofrequency (RF) module: "In vivo study for the removal of wrinkles by means of Radiofrequency." (No specific performance data or success criteria provided for this study).

Explanation: The documentation states the TattooStar Effect Y is "another safe and effective device" and details its intended uses and specific indications for different wavelengths and modules. However, it does not present quantifiable acceptance criteria (e.g., "The device must achieve X% clearance of red tattoo pigment in Y% of patients") or provide detailed performance data against such criteria. The "safety and effectiveness" argument is primarily built on the substantial equivalence to predicate devices, not on meeting specific, pre-defined performance thresholds for the TattooStar Effect Y itself in a dedicated study (except for the mention of the RF study, which lacks details).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- For the Radiofrequency (RF) module's "in vivo study for the removal of wrinkles": Not specified. The document simply states "In vivo study" without providing any details about the number of subjects or cases included.
- For other indications (tattoos, pigmented lesions, hair removal, etc.): Not applicable. No dedicated, new "test set" or clinical study with a specified sample size is described for these indications for the TattooStar Effect Y device. The substantial equivalence argument relies on the performance of predicate devices.
Data Provenance (Country of Origin, Retrospective/Prospective):
- For the RF module's "in vivo study": Not specified. There is no information about the country where this study was conducted or whether it was retrospective or prospective.
- For other indications: The basis for claiming safety and effectiveness for other indications is the substantial equivalence to predicate devices (Spectra K071451, K103455; Dermablate Effect K081541; Aluma K051214; Ellipse Flex PPT K052688). The original clinical data for these predicate devices would have their own provenance, but it's not provided for the TattooStar Effect Y submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable / Not specified.
- For the described "in vivo study for the removal of wrinkles," there is no mention of external experts being used to establish a ground truth. Clinical studies for device efficacy typically measure changes directly (e.g., depth of wrinkles, objective scores) rather than requiring expert consensus on a "ground truth" in the way an AI diagnostic algorithm might.
- For the overall device, the "ground truth" for safety and effectiveness is implicitly established by the regulatory clearance of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable / Not specified.
- Given the nature of the "in vivo study" for wrinkles (likely direct measurement or physician assessment of change), a multi-reader adjudication method as described (e.g., 2+1) is not typically used for this type of clinical outcome.
- No other "test set" requiring adjudication or expert consensus is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done.
- This type of study is usually conducted for AI-powered diagnostic or decision support tools to assess how AI assistance impacts human reader performance. The TattooStar Effect Y is a laser device for medical procedures, not a diagnostic imaging tool with an AI component in the sense of image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable.
- This concept is relevant for AI algorithms. The TattooStar Effect Y is a physical medical device. While it may have internal software controlling laser parameters, it is not an "algorithm" in the context of standalone performance evaluation for diagnostic or interpretative tasks.

7. Type of Ground Truth Used

For the "in vivo study for the removal of wrinkles": Likely clinical assessment (e.g., physician's global aesthetic improvement scale, objective wrinkle measurement techniques) of the treated area. The document doesn't provide details, but this is the typical "ground truth" for studies on aesthetic improvements.
For other indications: The "ground truth" for the overall device's safety and effectiveness for its stated indications is based on the established performance and safety profiles of the predicate devices cleared by regulatory bodies.

8. Sample Size for the Training Set

Not applicable. The TattooStar Effect Y is a physical medical device, not an AI algorithm that requires a "training set" in the machine learning sense. Any manufacturing, calibration, or internal software development wouldn't be referred to as a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As established in point 8, there is no "training set" in the context of this device.

Summary

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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

antje.katzer@asclepion.com

+49 3641 77 00 309

+49 3641 77 00 302

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:

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Intended Use:

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, skintype 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.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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:

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

Regulation Number and Section

§ 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.