(395 days)
Not Found
No
The summary describes a laser device with different wavelengths for various dermatological procedures and tattoo removal. There is no mention of AI, ML, image processing, or any data-driven algorithms in the device description, intended use, or performance studies.
No
A therapeutic device is one that treats or heals a disease or condition. While the device performs procedures like tattoo removal and skin resurfacing, which could be considered cosmetic or elective, the "removal of pigmented lesions" and "hyperpigmented burn and boil scar" could sometimes fall under therapeutic depending on the underlying pathology and medical necessity for removal. However, the listed indications are primarily for aesthetic and superficial modifications rather than directly treating a medical disease or condition in a therapeutic sense. It's more of a surgical/ablative device for specific cosmetic or dermatological procedures, not primarily for treating disease. The language "incision, ablation and vaporization of soft tissue" is indicative of a surgical tool rather than a therapeutic one designed to heal or cure.
No
The device summary describes procedures such as incision, ablation, vaporization, and removal of tattoos and lesions, which are interventional/treatment procedures, not diagnostic ones.
No
The device description explicitly states it is a combination of a Nd:YAG laser and a Ruby laser, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TattooStar Effect Combo is a laser device that directly interacts with soft tissue for procedures like incision, ablation, vaporization, and tattoo/lesion removal. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes procedures performed on the patient's body, not analysis of samples from the patient's body.
Therefore, the TattooStar Effect Combo 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 Combo 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.
The TattooStar Effect Combo is indicated for incision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions and skin resurfacing procedures. Depending on the wavelength selected, the indications are as follows:
1064 nm: Removal of black and blue tattoo color, Skin resurfacing
532 nm: Removal of pigmented lesions (including but not limited to lentigo benigna, hyperpigmented bum and boil scar, naevus Ota / Ito, freckles, Becker naevi, Cafe-au-lait spots), Removal of red tattoo color
585 nm: Removal of sky blue tattoo color
694nm: Removal of pigmented lesions, Removal of black, blue and green tattoo color
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The TattooStar Effect Combo is a combination of a Nd:YAG laser and a Ruby laser. Both lasers are pulsed q-switched lasers, the Nd:YAG can optionally emit millisecond pulses in the Free-running mode. The Nd:YAG laser emits wavelengths of 1064nm and 532nm. The beam can be converted to 585nm by means of an optional dye handpiece. The Ruby laser emits 694 nm radiation.
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
general dermatology
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: None
Conclusion: The TattooStar Effect Combo 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.
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.
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
510(k) SUMMARY ASCLEPION LASÈR TECHNOLOGIES GmbH TattooStar Effect Combo
JUL 17 2014 KI31757
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH TattooStar Effect Combo is submitted in accordance with the requirements of 21 CFR 807.92 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 Manager and
International Regulatory Affairs Manager | |
| Phone:
Fax:
e-mail: | +49 3641 77 00 309
+49 3641 77 00 302
antje.katzer@asclepion.com | |
| Preparation Date: | July 15, 2014 | |
| Device Name: | TattooStar Effect Combo | |
| Common Name: | q-switch laser | |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery
and in dermatology
79-GEX
21 CFR 878.4810 | |
| Equivalent Devices: | TattooStar Effect Y
TattooStar R | K112669
K060787 |
| Device Description: | The TattooStar Effect Combo is a combination of a Nd:YAG laser
and a Ruby laser. Both lasers are pulsed q-switched lasers, the
Nd:YAG can optionally emit millisecond pulses in the Free-
running mode. The Nd:YAG laser emits wavelengths of 1064nm
and 532nm. The beam can be converted to 585nm by means of
an optional dye handpiece. The Ruby laser emits 694 nm
radiation. | |
1
The TattooStar Effect Combo is indicated for incision, Intended Use: 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.
| Proposed Modified Device | Un-Modified Predicate Device | |
|---|---|---|
| Name | TattooStar Effect Combo | |
| Modul: R (Ruby laser) | TattooStar R | |
| K060787 | ||
| Indications | Incision, excision, vaporization | |
| and ablation of soft tissue, the | ||
| removal of tattoos and benign | ||
| pigmented lesions | Cutting, vaporization and | |
| ablation of soft tissue, the | ||
| removal of tattoos and of benign | ||
| pigmented lesions | ||
| There are the same treatment recommendations for both systems: | ||
| 694nm: Removal of pigmented lesions: 3 J/cm², 4-5.5 mm, 0.5-2 Hz, 40 ns | ||
| Removal of black, blue and green tattoo: 2-3 J/cm², 4-5.5 mm, 0.5-2 Hz, 40 ns | ||
| Device Type | Ruby | Ruby |
| Delivery | Articulated mirror arm | Articulated mirror arm |
| Wavelength | 694 nm | 694 nm |
| Max. Energy per | ||
| Pulse | 1,15 J | 1,2 J |
| Max. Fluence on | ||
| skin | 25 J/cm² | 20 J/cm² |
| Pulse Duration | ||
| q-switch | 40 ns | 40 ns |
| Repetition Rate | Up to 2 Hz | Up to 2 Hz |
| Spot Sizes | 2 – 7 mm | 2,5 - 6 mm |
| Proposed Modified Device | Un-Modified Predicate Device | |
| Name | TattooStar Effect Combo | |
| Modul: Y (Nd:YAG laser) | TattooStar Effect Y | |
| Modul: Y (Nd:YAG laser) | ||
| K112669 | ||
| Indications | Incision, excision, vaporization and | |
| ablation of soft tissue, the removal of | ||
| tattoos, pigmented lesions, vascular | ||
| lesions and hair and skin resurfacing | ||
| procedures | Incision, excision, vaporization | |
| and ablation of soft tissue, the | ||
| removal of tattoos, pigmented | ||
| lesions, vascular lesions and hair | ||
| and skin resurfacing procedures | ||
| There are the same treatment recommendations for both systems: | ||
| 1064 nm: Removal of black and blue tattoo color: | ||
| 3-3.5 J/cm², 2-4 mm, 1-10 Hz, 8 ns | ||
| Skin resurfacing: | 1.5-2.5 J/cm², 5.5 mm, | |
| 10 Hz, 0.3 ms | ||
| 1.5 J/cm², | ||
| 7 mm, | ||
| 2-5 Hz, 8 ns | ||
| 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): | ||
| 2-2.5 J/cm², | ||
| 4 mm, | ||
| 1-5 Hz, | ||
| 8 ns | ||
| Removal of red tattoo color: | 2 J/cm², | |
| 4 mm, | ||
| 1-5 Hz, | ||
| 8 ns | ||
| 585 nm: Removal of sky blue tattoo color: | 2-3 J/cm², | |
| 2.5 mm, | ||
| 1-5 Hz, | ||
| 8 ns | ||
| Device Type | Nd :YAG | Nd :YAG |
| Delivery | Articulated mirror arm | Articulated mirror arm |
| Wavelength | 1064 / 532 / 585 nm | 1064 / 532 / 585 nm |
| Max. | ||
| Energy per | ||
| Pulse | 1064 nm: 0,8 J (q-switch mode) | |
| 1064 nm: 1,5 J (free running mode) | ||
| 532 nm: 0,4 J (q-switch mode) | ||
| 585 nm: 0,25 J (q-switch mode) | 1064 nm: 0,8 J (q-switch mode) | |
| 1064 nm: 1,5 J (free running mode) | ||
| 532 nm: 0,4 J (q-switch mode) | ||
| 585 nm: 0,25 J (q-switch mode) | ||
| Max. | ||
| Fluence on | ||
| skin | 20 J/cm² (q-switch mode) | |
| 37 J/cm² (free running mode) | 20 J/cm² (q-switch mode) | |
| 37 J/cm² (free running mode) | ||
| Pulse | ||
| Duration | ||
| q-switch | 8 ns (q-switch mode) | |
| 300 µs (free running mode) | 8 ns (q-switch mode) | |
| 300 µs (free running mode) | ||
| Repetition | ||
| Rate | Up to 10 Hz | Up to 10 Hz |
| Spot Sizes | 2 – 7 mm | 2 – 7 mm |
2
.
·
・
.
3
The TattooStar Effect Combo is substantially equivalent to Comparison to: the TattooStar Effect Y Laser system and to the TattooStar R with the same principles of operation, with the same parameters and with the same indications for use.
Nonclinical Performance Data: None
Clinical Performance Data: None
Conclusion: The TattooStar Effect Combo 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.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Control - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2014
Asclepion Laser Technologies GmbH Mr. Antje Katze Regulatory Affairs Manager Bruesseler Street 10 Jena, Germanv 07747
Re: K131757
Trade/Device Name: TattooStar Effect Combo 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: June 20, 2014 Received: June 24, 2014
Dear Mr. 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
5
Page 2 - Mr. Antje Katze
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131757
Device Name TattooStar Effect Combo
Indications for Use (Describe)
The TattooStar Effect Combo is indicated for incision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions and skin resurfacing procedures. Depending on the wavelength selected, the indications are as follows:
| Wavelength | Indication | Recommended Parameters for the Beginning |
|---|---|---|
| 1064 nm: | Removal of black and blue tattoo color | 3-3.5 J/cm^2, 2-4 mm, 1-10Hz, 8 ns |
| Skin resurfacing | 1.5-2.5 J/cm^2, 5.5 mm, 10 Hz, 0.3 ms | |
| 1.5 J/cm^2, 7 mm, 2-5 Hz, 8 ns | ||
| 532 nm: | Removal of pigmented lesions | |
| (including but not limited to lentigo benigna, | ||
| hyperpigmented bum and boil scar, | ||
| naevus Ota / Ito, freckles, Becker naevi, | ||
| Cafe-au-lait spots) | 2-2.5 J/cm^2 4mm, 1-5Hz, 8 ns | |
| Removal of red tattoo color | 2 J/cm^2, 4mm, 1-5Hz, 8ns | |
| 585 nm: | Removal of sky blue tattoo color | 2-3 J/cm^2, 2.5mm, 1-5Hz, 8 ns |
| 694nm: | Removal of pigmented lesions | 3 J/cm^2, 4-5.5 mm, 0.5-2 Hz, 40 ns |
| Removal of black, blue and green | ||
| tattoo color | 2-3 J/cm^2, 4-5.5 mm, 0.5-2 Hz, 40 ns | |
| Type of Use (Select one or both, as applicable) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.07.17 11:18:23 -04'00' > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."