K043586 · Mettler Electronics Corp. · ILY · May 6, 2005 · Physical Medicine
Device Facts
Record ID
K043586
Device Name
LASER SYS*STIM 540, MODEL ME 540
Applicant
Mettler Electronics Corp.
Product Code
ILY · Physical Medicine
Decision Date
May 6, 2005
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 890.5500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Laser Sys*Stim, Model ME 540, is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscles.
Device Story
Laser Sys*Stim 540 is a portable, AC/battery-operated infrared lamp for low-level laser therapy (LLLT). System comprises a drive unit/power supply with electronics, controls, and displays, plus optional treatment probes containing visible and infrared radiating elements. Device emits infrared energy to elevate tissue temperature. Used in clinical settings by healthcare providers to treat minor muscle/joint pain, stiffness, arthritis, and muscle spasms. Output is topical heat; clinical benefit is temporary pain relief, increased local circulation, and muscle relaxation.
Clinical Evidence
No clinical data. Substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices. Production and quality control performance and safety testing are performed to ensure compliance with applicable safety standards for low-level laser therapy systems.
Technological Characteristics
Portable infrared lamp; AC/battery-powered. Uses visible and infrared laser diodes for topical heating. System includes drive unit/power supply and optional treatment probes. Regulated under 21 CFR 890.5500 (Product Code ILY).
Indications for Use
Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain, stiffness, minor arthritis pain, muscle spasm, increased local blood circulation, and muscle relaxation.
Regulatory Classification
Identification
An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.
Special Controls
*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Dynatronics' Solaris D880 Infrared Probe (K031329)
Submission Summary (Full Text)
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MAY - 6 2005
# LASER SYS*STIM® 540 MODEL ME 540 510(K) SUMMARY STATEMENT [K(TBD)]
043586
Mettler Electronics Corp. Submitter's Name: 1333 South Claudina Street Address: Anaheim, CA 92805 800-854-9305 or 714-533-2221 x314 Telephone: 714-781-8984 Fax: Rob Fleming, Regulatory Compliance Manager Contact: and Official Correspondent robfleming@mettlerelectronics.com Email:
December 22, 2004 Date Prepared:
#### Device Name:
- a. TRADE NAME:
- b. CLASSIFICATION NAME:
- c. COMMON NAME:
Laser Sys*Stim 540, Model ME 540 Infrared Lamp Low Level Laser Therapy (LLLT)
#### Predicate Devices:
In our opinion, the Laser Sys*Stim® 540, Model ME 540, is substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. These predicate devices include the MedX 1100 Console (K032231), Dynatronics' Solaris D890 Therapy Probe (K040729) and Dynatronics' Solaris D880 Infrared Probe (K031329).
### Description of Device:
The Laser Sys*Stim 540, Model ME 540, is a portable, AC and battery operated non-invasive, low level infrared lamp that provides continuous and pulsed heat therapy at a fixed frequency. The system consists of a drive unit/power supply that houses the electronics, controls and displays and optional treatment probes that contain the visible and infrared radiating elements.
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# LASER SYS*STIM® 540 MODEL ME 540 510(K) SUMMARY STATEMENT [K(TBD)]
#### Device Intended Use Statement:
510(k) Number: TBD
Device Name: Laser Sys*Stim, Model ME 540
Indication for use: The Laser Sys*Stim, Model ME 540, is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscles.
### Comparison of Technological Characteristics Between ME 540 and Predicate Devices:
The Laser Sys*Stim, Model ME 540, and predicate devices listed above, are infrared lamps as defined in 21 CFR 890.5500 using infrared and visible laser diodes that generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.
#### Testing:
Production and quality control performance and safety testing shall be performed on each system pursuant to compliance with all applicable safety standards and regulations for low level laser therapy systems.
### Conclusion:
The Laser Sys*Stim, Model ME 540, is substantially equivalent to, and shares the same indications for use, general technical characteristics and user interface controls as, the listed predicate devices. It is designed to provide topical heating in the infrared and visible wavelength spectrum at energy levels previously found acceptable by the Food and Drug Administration. Each unit shall undergo compliance verification testing prior to introduction into interstate commerce to insure conformance to specifications and applicable safety standards.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features the department's name encircling a symbol. The symbol consists of four stylized, abstract shapes that resemble human figures or birds in flight. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2005
Mr. Robert E. Fleming Regulatory Compliance Manager Mettler Electronics Corporation 1333 South Claudina Street Anaheim, California 92805
Re: K043586
Trade/Device Name: Laser Sys*Stim 540, Model ME 540 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: March 9, 2005 Received: March 10, 2005
Dear Mr. Fleming:
We have reviewed your Section 510(k) premarket notification of intent to market the device w Chave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to Connieres that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercrore, market the Act include requirements for annual registration, listing of general controls providering 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oous of concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Drivice complies with other requirements of the Act that I DA has made a actering administered by other Federal agencies. You must of ally I cuclar statutes and regalances ancluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, 01); good manufacturing practice requirements as set CFR art 6077, laboring (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Robert E. Fleming
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to oegin maine of substantial equivalence of your device to a legally premarket notification: "The PDF 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 If you desire specific advice for your do november 10 . Also, please note the regulation entitled, Condor the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain Misolanding of Icrerchee to premainsvilibilities under the Act from the Division of Small other general Information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting 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
510(k) Number (if known):
Device Name: Laser Sys*Stim 540, Model ME 540
Indications for Use:
The Laser Sys*Stim 540, Model ME 540 is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscles.
Prescription Use X (Per 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
tive
043586
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.
