K180555 · Jk Holding GmbH · LEJ · Oct 11, 2018 · General, Plastic Surgery
Device Facts
Record ID
K180555
Device Name
Ergoline Prestige 1600 Hybrid Performance
Applicant
Jk Holding GmbH
Product Code
LEJ · General, Plastic Surgery
Decision Date
Oct 11, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4635
Device Class
Class 2
Indications for Use
This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
Device Story
Sunlamp product for aesthetic tanning; utilizes artificial UV radiation sources (UV-A and UV-B) and mechanical structure. Operates by exposing human skin to controlled UV intensities to induce tanning. Used in professional tanning facilities; operated by adult users. Device incorporates 52 body lamps (38 UV, 14 UV+red light), 4 high-pressure facial lamps, and 3 UV-B facial lamps. Electronic ballasts reduce power consumption compared to predicate. Safety verified via irradiance characteristics, electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) testing. Benefits include cosmetic skin tanning.
Clinical Evidence
Bench testing only. Compliance verified with ISO 10993 (biocompatibility), IEC 60601-1 (electrical/mechanical safety), IEC 60601-1-2 (EMC), and 21 CFR 1040.20 (performance standard for sunlamp products).
Technological Characteristics
Sunlamp booth; 52 body lamps (200W), 4 high-pressure facial lamps (520W), 3 UV-B facial lamps (8W). Uses electronic ballasts. Complies with IEC 60601-1, IEC 60601-1-2, and 21 CFR 1040.20. Irradiance ratio max 0.003.
Indications for Use
Indicated for aesthetic tanning of human skin for individuals aged 18 and older. Contraindicated for persons under 18.
Regulatory Classification
Identification
A sunlamp product is any device designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. This definition includes tanning beds and tanning booths. A UV lamp intended for use in sunlamp products is any lamp that produces UV radiation in the wavelength interval of 200 to 400 nanometers in air.
Special Controls
*Classification.* Class II (special controls). The special controls for sunlamp products and UV lamps intended for use in sunlamp products are:(1) Conduct performance testing that demonstrates the following:
(i) Device meets appropriate output performance specifications such as wavelengths, energy density, and lamp life; and
(ii) Device's safety features, such as timers to limit UV exposure and alarms, function properly.
(2) Demonstrate that device is mechanically safe to prevent user injury.
(3) Demonstrate software verification, validation, and hazard analysis.
(4) Demonstrate that device is biocompatible.
(5) Demonstrate that device is electrically safe and electromagnetically compatible in its intended use environment.
(6)
*Labeling* —(i)*Sunlamp products.* (A) The warning statement below must appear on all sunlamp products and must be placed in a black box. This statement must be permanently affixed or inscribed on the product when fully assembled for use so as to be legible and readily accessible to view by the person who will be exposed to UV radiation immediately before the use of the product. It shall be of sufficient durability to remain legible throughout the expected lifetime of the product. It shall appear on a part or panel displayed prominently under normal conditions of use so that it is readily accessible to view whether the tanning bed canopy (or tanning booth door) is open or closed when the person who will be exposed approaches the equipment and the text shall be at least 10 millimeters (height). Labeling on the device must include the following statement: Attention: This sunlamp product should not be used on persons under the age of 18 years. (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions.
(ii)
*Sunlamp products and UV lamps intended for use in sunlamp products.* Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements:(A) “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
(B) “Contraindication: This product must not be used if skin lesions or open wounds are present.”
(C) “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
(D) “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
(c)
*Performance standard.* Sunlamp products and UV lamps intended for use in sunlamp products are subject to the electronic product performance standard at § 1040.20 of this chapter.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in two lines.
JK Holding GmbH Juergen Gerstenmeier Director Research & Development Koehlershohner Strasse 60 Windhagen, 53578 De
October 11, 2018
Re: K180555
Trade/Device Name: Ergoline Prestige 1600 Hybrid Performance Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet lamp for tanning Regulatory Class: Class II Product Code: LEJ Dated: August 7, 2018 Received: August 14, 2018
Dear Juergen Gerstenmeier:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Neil R Ogden -S 2018.10.11 08:49:06 -04'00'
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known) K180552
Device Name Ergoline Prestige 1600 Hybrid Performance
Indications for Use (Describe)
This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <span style="display: inline-block;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="display: inline-block;">☑ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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# 510(k) Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act, JK HOLDING GmbH herewith submits a Summary of Safety and Effectiveness.
This 510(k) summary for the Ergoline Prestige 1600 Hybrid Performance meets the requirements of 21 CFR 807.92
| Submitter information: | JK HOLDING GmbH<br>Koehlershohner Strasse 60<br>53578 Windhagen<br>Phone: +49 (0) 2224 / 818-0<br>Fax: +49 (0) 2224 / 818-116 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration Number: 961502-<br>Owner/Operator Number: 9034303 |
| Official Correspondent: | Jürgen Gerstenmeier<br>Koehlershohner Strasse 60<br>53578 Windhagen<br>Germany<br>Phone: +49 (0) 2224 / 818-330<br>Email: juergen.gerstenmeier@de.jk-group.net |
| US Agent (Contact): | Kevin Hart<br>JK PRODUCTS & SERVICES, INC.<br>411 West Washington Ave Suite B<br>Jonesboro , AR 72401<br>Phone: 870-2682862<br>Fax: 870 9359046<br>Email: Kevin.Hart@Jkamerica.com |
| Date Prepared: | September 07th, 2018 |
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# Device(s) Identification:
| Device trade name: | Ergoline Prestige 1600 Hybrid Performance |
|--------------------|-------------------------------------------|
| Common name: | Sunlamp product |
| Model No.: | JK 162 / 52-4 TT HP |
#### Classification of the device:
| Device Classification Name: | Booth, Sun Tan |
|-----------------------------|---------------------------|
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
## Device Description:
The primary technical components of sunlamp products are artificial sources of UV radiation and a mechanical structure.
Different UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin.
The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.
#### Indications for use:
This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
## Predicate device:
| Device Name: | Ergoline/Prestige 1400 Intelligent Performance |
|-----------------------------|------------------------------------------------|
| 510k number: | K151400 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
| | |
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# Comparison to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate device and the proposed device.
| Parameter | Predicate device<br>Ergoline/Prestige 1400<br>Intelligent Performance | Proposed device<br>Ergoline Prestige<br>1600 Hybrid<br>Performance | Evaluation |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This sunlamp product<br>is intended exclusively<br>for cosmetic tanning of<br>the human skin, for<br>one person at a time,<br>at the age of 18 or<br>above. | This sunlamp<br>product is intended<br>exclusively for<br>cosmetic tanning of<br>the human skin, for<br>one person at a time,<br>at the age of 18 or<br>above. | Identical |
| Number of body lamps | 52<br>(all UV lamps) | 52<br>(38 UV lamps, 14<br>UV+red light lamps) | Similar:<br>The irradiance<br>characteristics are<br>still comparable as<br>provided under<br>section 18. The safety<br>has been confirmed<br>additionally by<br>corresponding tests in<br>accordance with IEC<br>62471.<br>In terms of<br>functionality and<br>safety there is no<br>impact due to this<br>difference. |
| Watts | 200 | 200 | Identical |
| Lamp item description | GENESIS VHP10<br>Intelligent Performance<br>- 200 W | GENESIS Type U<br>Hybrid Performance -<br>200 W<br>(UV light)<br>GENESIS Type R<br>Hybrid Performance -<br>200 W<br>(red light) | Similar:<br>The irradiance<br>characteristics are<br>still comparable as<br>provided under<br>section 18. The safety<br>has been confirmed<br>additionally by<br>corresponding tests in<br>accordance with IEC<br>62471.<br>In terms of |
| Parameter | Predicate device<br>Ergoline/Prestige 1400<br>Intelligent Performance | Proposed device<br>Ergoline Prestige<br>1600 Hybrid<br>Performance | Evaluation |
| | | | functionality and<br>safety there is no<br>impact due to this<br>difference |
| Number of High<br>Pressure Facial lamps | 4 | 4 | Identical |
| Watts | 520 | 520 | Identical |
| Lamp item description | Ergoline Ultra 520W | Ergoline Ultra 520W | Identical |
| Filter | Ultra Performance 412 | Ultra Performance<br>412 | Identical |
| Number of UV-B<br>Facial lamps | 3 | 3 | Identical |
| Watts | 8 | 8 | Identical |
| Lamp item description | Genesis VHP B-Power<br>E9 8W | Genesis Type R<br>Hybrid 8W | Similar |
| Number of Shoulder<br>lamps | 2 | 2 | Identical |
| Watts | 240 | 240 | Identical |
| Lamp item description | Ergoline Ultra 250W | Ergoline Ultra 250W | Identical |
| Filter | Ultra Performance 912 | Ultra Performance<br>912 | Identical |
| Max exposure time<br>[min] | 10 | 10 | identical |
| Electrical<br>requirements | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | identical |
| Total power<br>consumption [watts] | 18,500 W | 17,600 W | Similar: less power<br>consumption due to<br>the use of electronic<br>ballasts instead of<br>magnetic ballasts.<br>Performance is not<br>impaired. |
| Rated overcurrent<br>protection device<br>(circuit breaker) | 70A / 3-pole 3Ø or<br>100A / 2-pole 2Ø | 70A / 3-pole 3Ø or<br>100A / 2-pole 2Ø | identical |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | identical |
| Irradiance ratio in<br>accordance with<br>1040.20<br>(max. 0.003) | fulfilled | fulfilled | identical<br>(refer to section 18 for<br>bench test reports) |
| Parameter | Predicate device<br>Ergoline/Prestige 1400<br>Intelligent Performance | Proposed device<br>Ergoline Prestige<br>1600 Hybrid<br>Performance | Evaluation |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | identical |
| Electromagnetic<br>compatibility | IEC 60601-1-2 | IEC 60601-1-2 | identical |
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# Summary of performance testing:
The proposed device has been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed device is in compliance with U.S. performance standard 21CFR 1040.20. All proposed sunlamp products are in compliance with U.S. performance standard 1040.20.
#### Conclusion:
JK Holding GmbH believes that the Ergoline Prestige 1600 Hybrid Performance is substantially equivalent to currently legally marketed devices. Also all special controls are fulfilled. This device does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
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.
