(240 days)
Not Found
No
The summary describes a laser system with optional modules (pulsed light, radiofrequency, acoustic wave) for various dermatological procedures. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is indicated for various dermatological and surgical procedures, including tattoo and hair removal, lesion treatment, and skin resurfacing, which are primarily cosmetic or aesthetic in nature rather than therapeutic for diseases.
No
Explanation: The provided text describes the TattooStar Effect Y as a laser device for various soft tissue treatments and removal procedures (e.g., tattoos, hair, lesions, wrinkles). It does not mention any function related to diagnosing medical conditions.
No
The device description clearly indicates it is a pulsed Nd:YAG solid state laser system with optional hardware modules (pulsed light, radiofrequency, acoustic wave). This is a hardware-based medical device, not software-only.
Based on the provided information, the TattooStar Effect Y device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- TattooStar Effect Y Function: The description clearly states that the TattooStar Effect Y is a laser system used for direct treatment of the human body (incision, excision, ablation, vaporization of soft tissue, tattoo removal, hair removal, skin resurfacing, wrinkle treatment, connective tissue activation). It operates on the patient's body, not on specimens taken from the body.
- Lack of Specimen Handling: There is no mention of the device being used to analyze or process biological specimens.
Therefore, the TattooStar Effect Y falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K071451, K103455, K081541, K051214, K052688
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
+49 3641 77 00 309
+49 3641 77 00 302
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).
1
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.
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
2
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.
3
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
4
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,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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