(69 days)
Medlite C6
Not Found
No
The summary describes a laser device with specific wavelengths and delivery system, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as being used for medical procedures such as incision, excision, ablation, vaporization of soft tissue, and the removal of lesions and hair, which are therapeutic interventions.
No
The device is described as a laser for the incision, excision, ablation, and vaporization of soft tissue, and the removal of hair and lesions. These are therapeutic, not diagnostic, uses.
No
The device description clearly states it is a q-switched solid state laser with a laser enclosure and optic delivery system, indicating it is a hardware device.
Based on the provided information, the TattooStar Y is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed directly on the patient's body (incision, excision, ablation, vaporization of soft tissue, removal of hair, benign pigmented lesions, vascular lesions). IVDs are used to examine specimens taken from the body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The device is a laser system with an optical delivery system, designed for direct application to the body. IVDs are typically laboratory instruments or test kits used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory results.
Therefore, the TattooStar Y is a therapeutic laser device used for dermatological procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TattooStar Y 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.
Product codes
GEX
Device Description
The TattooStar Y is a q-switched solid state lasers emitting wavelengths of 1064, 532 and 585 nm. It consists of a laser enclosure and optic delivery system (articulated mirror arm).
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
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
Not Found
Predicate Device(s)
Medlite C6
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 LASER TECHNOLOGIES GmbH TattooStar Y
AUG - 1 2007
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH TattooStar 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
Am Semmicht 1A
07751 Jena, Germany |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mrs Antje Katzer
Product Management and
International Regulatory Affairs |
| Phone:
Fax:
e-mail: | +49 3641 77 00 309
+49 3641 77 00 302
antje.katzer@asclepion.com |
| Preparation Date: | May 21th, 2007 |
| Device Name: | TattooStar Y |
| Common Name: | TattooStar Y |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.481 |
| Equivalent Device: | Medlite C6 |
| Device Description: | The TattooStar Y is a q-switched solid state lasers emitting
wavelengths of 1064, 532 and 585 nm. It consists of a laser
enclosure and optic delivery system (articulated mirror arm). |
| Intended Use: | The TattooStar Y 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. |
| Comparison to: | The TattooStar Y is substantially equivalent to the Medlite
C6, with the same principles of operation, and the same
indication for use. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The TattooStar Y is another safe and effective device
for incision, excision, ablation, vaporization of soft
tissue for general dermatology and the removal of
tattoos, pigmented lesions, vascular lesions and hair. |
| Additional Information : | None |
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Qaita 9 unn 2
:
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EXHIBIT F
INDICATION FOR USE STATEMENT
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asclepion Laser Technologies % Antje Katzer 1A; IM SEMMICHT JENA, GERMANY 07751
AUG = 1 2007
Re: K071451 Trade/Device Name: TattooStar Y Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and and in dermatology Regulatory Class: II Product Code: GEX Dated: June 29, 2007 Received: July 2, 2007
Dear Antje 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.
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 – Antje Katzer
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours, ハモ 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):
Device Name: TattooStar Y
Indications for Use:
The TattooStar Y is intended for use for incision, excision, ablation, vaporization The Tattoostal T is Intended for use for the belows of tattoos, the removal of hair of soft tissue for general dematology and the romovial of hair.
benign pigmented lesion, the removal of vascular lesion and the removal of hair.
Division Signa
vision Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K071481 k11
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)