K151962 · Kbl AG · LEJ · Sep 15, 2016 · General, Plastic Surgery
Device Facts
Record ID
K151962
Device Name
KBL Sunlamp Products (= Device Bundling name)
Applicant
Kbl AG
Product Code
LEJ · General, Plastic Surgery
Decision Date
Sep 15, 2016
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4635
Device Class
Class 2
Indications for Use
KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning of the human skin of an adult person.
Device Story
KBL Sunlamp Products are whole-body tanning devices; available as horizontal tanning beds or vertical tanning towers. Devices consist of mechanical structures equipped with artificial light sources (UVA/UVB lamps). Users stand or lie within the device to receive UV irradiation for skin tanning. UVA light generates rapid, intensive superficial tan; UVB light generates long-term tanning results. Devices are intended for over-the-counter use by adults. Operation involves setting exposure times within FDA-compliant limits. Output is controlled UV light exposure; intended to induce skin tanning.
Clinical Evidence
Bench testing only. Testing included biocompatibility (DIN EN ISO 10993-1, -5, -12), electrical/mechanical safety (IEC 60601-1, IEC 60335-1, UL482), electromagnetic compatibility (IEC 60601-1-2), spectral emission measurement (IEC 60335-2-27), and performance standards testing per 21 CFR 1040.20. Software verification and validation were performed per FDA guidance.
Technological Characteristics
Mechanical tanning structures (beds/towers) with UVA/UVB lamps. Electrical/mechanical safety per IEC 60601-1/IEC 60335-1/UL482. Biocompatibility per DIN EN ISO 10993. Spectral emission per IEC 60335-2-27. Compliance with 21 CFR 1040.20 for irradiance ratios and timer intervals.
Indications for Use
Indicated for tanning of the human skin of an adult person.
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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of three intertwined human profiles facing to the right, symbolizing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2016
KBL AG Mr. Norbert Becker Head of Technical Department Ringstrasse 24-26 Dernbach, Rheinland-Pfalz, Germany 56307
Re: K151962
Trade/Device Name: KBL Sunlamp Products Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet lamp for tanning Regulatory Class: Class II Product Code: LEJ Dated: September 12, 2016 Received: September 14, 2016
Dear Mr. Becker:
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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 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 Parts 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
## Christopher J. Ronk -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
### 510(k) Number (if known)
### K151962
Device Name
### KBL Sunlamp Products
Indications for Use (Describe)
KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVB and
UVA region of the spectrum intended for tanning of the human skin of an adult person.
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> 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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-5740
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Image /page/3/Picture/0 description: The image shows the logo for KBL AG, which is "The Beauty & Health Company". The logo consists of a yellow circle with white lines inside, followed by the letters "KBL" in gray. The letters "AG" are in a smaller font and are located to the right of the "L". A yellow line is underneath the letters, and the text "The Beauty & Health Company" is underneath the yellow line.
## 510(k) SUMMARY
(according to 21 CFR 807.92)
### 1. GENERAL INFORMATION
| Submitter: | KBL AG<br>Ringstrasse 24-26<br>56307 Dernbach, GERMANY<br>Phone: +49 (0) 2689 9426-0<br>Fax: +49 (0) 2689 9426-66 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Norbert Becker<br>Ringstrasse 24-26<br>56307 Dernbach, GERMANY<br>Phone: +49 (0) 2689 9426-525<br>Fax: +49 (0) 2689 9426-500<br>E-mail: nbecker@kbl.de |
# 2. PROPOSED DEVICE(S)
Preparation date:
| Device Bundling Name: | KBL Sunlamp Product |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name(s): | KBL 6800 alpha / KBL 7900 alpha<br>KBL 4800 alpha / KBL 5600 alpha<br>KBL Tower Space 2000 / KBL Tower Space 3000<br>KBL Tower pure Energy 5.0 |
| Common Name | Tanning device |
| Classification Name: | Sunlamp product (21 CFR 878.4635, Product Code LEJ) |
June 8, 2015
All Proposed Devices have originally been listed as Class I devices (510(k)-exempt sunlamp products) and legally offered for sale before September 2, 2014. In accordance with the Final Order (Federal Register, Volume 79, Number 5) the proposed devices are used as Predicate Devices for Substantial Equivalence purposes.
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Image /page/4/Picture/0 description: The image shows the logo for KBL AG, a beauty and health company. The logo features a yellow circle with white lines inside, followed by the letters "KBL" in gray. Below the letters is a yellow line, and below that is the text "The Beauty & Health Company" in gray.
## 3. PREDICATE DEVICE(S)
| Trade Name(s): | KBL 6800 alpha / KBL 7900 alpha<br>KBL 4800 alpha / KBL 5600 alpha<br>KBL Tower Space 2000 / KBL Tower Space 3000<br>KBL Tower pure Energy 5.0 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Tanning device |
| Classification Name: | Sunlamp product (21 CFR 878.4635, Product Code LEJ) |
## 4. DEVICE DESCRIPTION
KBL Sunlamp Products are whole-body tanning devices basically consisting of a mechanical structure equipped with artificial light sources producing ultraviolet light in the UVA and UVB region of the light spectrum.
The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The UVA light primarily generates a superficial tan which appears rapidly and is intensive but also fades more rapidly whereas the UVB light generates more long term tanning results.
The user is either standing in the middle of the KBL Sunlamp Product if it is a vertical device (tanning tower) or lying on a bench if it is a horizontal device (tanning bed).
## 5. INDICATIONS FOR USE
The Indications for use for the Proposed Devices are identical to the Predicate Devices as shown in Table 1 below:
Table 1
| Proposed Device | Predicate Device |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person. | KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person. |
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Image /page/5/Picture/0 description: The image shows the logo for KBL AG, "The Beauty & Health Company". The logo consists of a yellow circle with white lines inside, followed by the letters "KBL" in gray. The letters "AG" are in smaller font and are located to the right of the "L". Below the letters is a yellow line, and below that is the text "The Beauty & Health Company".
## 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
We believe that the Technological Characteristics of the Proposed Devices in comparison to the Predicate Devices show that they are substantially equivalent (Table 2).
| Brand and type name ↓ | Number of Lamps Canopy | Watts | Number of Lamps Bench | Watts | Number of Facial Lamps | Watts | Number of Shoulder Lamps | Watts | Max. Exposure time in min | Dimentions in inches (height x width x depth) |
|------------------------------------------|----------------------------------|----------|-----------------------|-------|------------------------|-------|--------------------------|-------|---------------------------|------------------------------------------------------------------------------------------|
| Proposed Device<br>KBL 6800 alpha | 26 / 0 or<br>20 / 6 or<br>24 / 2 | 160 / 80 | 20 | 180 | 4 | 600 | 2 | 250 | 10 | when closed:<br>~60,39" x ~93,70" x ~56,30"<br>when open:<br>~76,46" x ~93,70" x ~56,30" |
| Predicate Device<br>KBL 6800 alpha | 26 / 0 or<br>20 / 6 or<br>24 / 2 | 160 / 80 | 20 | 180 | 4 | 600 | 2 | 250 | 10 | when closed:<br>~60,39" x ~93,70" x ~56,30"<br>when open:<br>~76,46" x ~93,70" x ~56,30" |
| Proposed Device<br>KBL 7900 alpha | 20 / 6 | 160 / 80 | 24 | 180 | 4 | 600 | 2 | 250 | 10 | when closed:<br>~67,44" x ~93,70" x ~56,30"<br>when open:<br>~82,16" x ~93,70" x ~56,30" |
| Predicate Device<br>KBL 7900 alpha | 20 / 6 | 160 / 80 | 24 | 180 | 4 | 600 | 2 | 250 | 10 | when closed:<br>~67,44" x ~93,70" x ~56,30"<br>when open:<br>~82,16" x ~93,70" x ~56,30" |
| Proposed Device<br>KBL 4800 alpha | 22 / 2 | 160 / 80 | 16 | 180 | 3 | 500 | N/A | N/A | 12 | when closed:<br>~53,94 x ~91,74 x ~62,21<br>when open:<br>~67,33 x ~91,74 x ~56,70 |
| Predicate Device<br>KBL 4800 alpha | 22 / 2 | 160 / 80 | 16 | 180 | 3 | 500 | N/A | N/A | 12 | when closed:<br>~53,94 x ~91,74 x ~62,21<br>when open:<br>~67,33 x ~91,74 x ~56,70 |
| Proposed Device<br>KBL 5600 alpha | 24 / 2 | 160 / 80 | 16 | 180 | 4 | 500 | N/A | N/A | 12 | when closed:<br>~58,27 x ~91,74 x ~63,39<br>when open:<br>~70,87 x ~91,74 x ~56,70 |
| Predicate Device<br>KBL 5600 alpha | 24 / 2 | 160 / 80 | 16 | 180 | 4 | 500 | N/A | N/A | 12 | when closed:<br>~58,27 x ~91,74 x ~63,39<br>when open:<br>~70,87 x ~91,74 x ~56,70 |
| Proposed Device<br>KBL Tower space 2000 | 50 | 180 | N/A | N/A | N/A | N/A | N/A | N/A | 11 | when closed:<br>85.83 x 55.12 x 55.31<br>when open:<br>85.83 x 55.12 x 77.28 |
| Predicate Device<br>KBL Tower space 2000 | 50 | 180 | N/A | N/A | N/A | N/A | N/A | N/A | 11 | when closed:<br>85.83 x 55.12 x 55.31<br>when open:<br>85.83 x 55.12 x 77.28 |
### Table 2
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Image /page/6/Picture/0 description: The image shows the logo for KBL AG, a beauty and health company. The logo features a yellow circle with lines inside, followed by the letters "KBL" in gray. Below the letters is a yellow line, and below that is the text "The Beauty & Health Company" in gray.
| Proposed<br>Device<br>KBL Tower<br>space 3000 | 52 | 180 | N/A | N/A | N/A | N/A | N/A | N/A | 11 | when closed:<br>85.83 x 55.12 x 58.98<br>when open:<br>85.83 x 55.12 x 77.09 |
|----------------------------------------------------|----|-----|-----|-----|-----|-----|-----|-----|----|------------------------------------------------------------------------------|
| Predicate<br>Device<br>KBL Tower<br>space 3000 | 52 | 180 | N/A | N/A | N/A | N/A | N/A | N/A | 11 | when closed:<br>85.83 x 55.12 x 58.98<br>when open:<br>85.83 x 55.12 x 77.09 |
| Proposed<br>Device<br>KBL Tower<br>pureEnergy 5.0 | 52 | 200 | N/A | N/A | N/A | N/A | N/A | N/A | 10 | when closed:<br>93,23 x 54,93 x 48,55<br>when open:<br>93,23 x 54,93 x 72,56 |
| Predicate<br>Device<br>KBL Tower<br>pureEnergy 5.0 | 52 | 200 | N/A | N/A | N/A | N/A | N/A | N/A | 10 | when closed:<br>93,23 x 54,93 x 48,55<br>when open:<br>93,23 x 54,93 x 72,56 |
## 7. PERFORMANCE DATA
The following non-clinical performance tests were performed for all proposed KBL sunlamp products:
- . Biocompatibility testing in accordance with DIN EN ISO 10993-1:2010-04; DIN EN ISO 10993-5:2009-10; DIN EN ISO 10993-12:2012-10;
- . Electrical and mechanical safety testing according to IEC 60601-1 Ed 3.1 2012/08 (IEC 60335-1:2010, 5te ed. and UL482:2005/09/02 Ed.9 Rev. 2013/10/03)
- Electromagnetic compatibility testing in compliance with IEC 60601-1-2:2007, modified. ●
- . Spectral emission measurement based on the test procedure for measuring the spectral emission in accordance to IEC 60335-2-27:2009, 5th ed.
- Software verification and validation testing according to FDA's Guidance for Industry and ● FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
- . Performance Standards testing in accordance with 21 CFR 1040.20
- Irradiance ratio limits are in accordance with 21 CFR 1040.20(c)(1). .
- . Maximum timer intervals and exposure schedules have been determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products".
## 8. CONCLUSION
Based on an analysis of the technological characteristics, non-clinical performance data and indications for use, KBL AG believes that the Proposed Devices are substantially equivalent to the legally marketed Predicate Devices and do not raise any new issues of safety and effectiveness.
### End of 510(k) Summary
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.
