K112669 · Asclepion Laser Technologies GmbH · GEX · May 11, 2012 · General, Plastic Surgery
Device Facts
Record ID
K112669
Device Name
TATTOOSTAR EFFECT Y
Applicant
Asclepion Laser Technologies GmbH
Product Code
GEX · General, Plastic Surgery
Decision Date
May 11, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
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. 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.
Device Story
Multi-modal dermatological system; combines pulsed Nd:YAG laser (1064nm, 532nm, optional 585nm dye handpiece) with optional Pulsed Light (APL), Radiofrequency (RF), and Acoustic Wave (AW) modules. Laser targets tissue via photothermolysis for tattoo removal, hair reduction, and resurfacing. APL uses specific spectral filters for acne, vascular/pigmented lesions, and hair removal. RF provides non-invasive wrinkle treatment; AW activates connective tissue. Operated by clinicians in dermatology/surgical settings. Output consists of controlled energy delivery to skin/tissue. Clinical benefit includes aesthetic improvement and lesion resolution. Device relies on modular attachments to expand treatment capabilities beyond standard laser surgery.
Clinical Evidence
No clinical data provided for the laser, APL, or AW modules. Clinical evidence limited to an in vivo study for the removal of wrinkles using the Radiofrequency module.
Technological Characteristics
Pulsed Nd:YAG solid-state laser; wavelengths 1064nm, 532nm, 585nm (dye). Modular architecture: APL (pulsed light), RF (radiofrequency), and AW (acoustic wave) modules. Energy delivery via handpieces. System is a floor-standing laser surgical instrument.
Indications for Use
Indicated for patients requiring soft tissue incision, excision, ablation, vaporization, tattoo removal, pigmented/vascular lesion treatment, hair reduction, skin resurfacing, acne treatment, or wrinkle reduction. Specific indications vary by wavelength (532/1064/585nm) and APL filter (400-1200nm range) based on skin type (I-IV) and hair/lesion characteristics.
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.
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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
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).
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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<br>type I-II |
| | Hair removal of blond, brown and black hair,<br>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,
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:
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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
