K011747 · Palomar Medical Technologies, Inc. · GEX · Aug 30, 2001 · General, Plastic Surgery
Device Facts
Record ID
K011747
Device Name
PALOMAR LC 100 DIODE LASER
Applicant
Palomar Medical Technologies, Inc.
Product Code
GEX · General, Plastic Surgery
Decision Date
Aug 30, 2001
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The LC100 diode laser system is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as a long-term, stable reduction in the number of re-growing hairs after a treatment regime. The LC100 is also indicated for photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, hemangioma, spider nevi, and other benign vascular lesions; photothermolysis of blood vessels (treatment of facial and leg veins); removal of benign pigmented lesions, including lentigines, nevi, chloasma, and café-au-lait; incision/excision, ablation and coagulation (homeostasis) of soft tissue. The LC100 is indicated for use in patients with skin types I-VI, including tanned patients.
Device Story
LC100 is a super long pulse diode laser system delivering 810 nm infrared light. System components include a chiller, footswitch, and handpiece with diode bars connected via umbilical. Handpiece features water-cooled tip for active skin cooling. Operated by clinicians in a clinical setting. User interface on top of laser unit controls parameters. Device delivers light pulses (50-1000 ms duration) to target tissue when footswitch is depressed. Clinical application involves pressing handpiece against patient skin to perform hair reduction, lesion treatment, or soft tissue surgery. Output is thermal energy for photothermolysis or coagulation. Benefits include non-invasive or minimally invasive treatment of dermatological conditions and soft tissue management.
Clinical Evidence
Bench testing only.
Technological Characteristics
810 nm diode laser; pulse duration 50-1000 ms; max repetition rate 3.3 Hz; 12x12 mm or 12x6 mm handpiece; water-cooled tip for active skin cooling; system computer with user interface panel.
Indications for Use
Indicated for hair removal, permanent hair reduction, treatment of benign pigmented/vascular lesions (e.g., port wine stains, telangiectasia, angioma, hemangioma, spider nevi, lentigines, nevi, chloasma, café-au-lait), and soft tissue incision/excision, ablation, and coagulation. Applicable to patients skin types I-VI, including tanned skin.
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.
{0}------------------------------------------------
## KO11747
## Attachment 5
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the LC100 Diode Array Laser System is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Palomar Medical Technologies, Inc. |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 82 Cambridge St.<br>Burlington, MA 01803 |
| Contact Person: | Marcy Moore |
| Telephone: | 919-363-2432 |
| Preparation Date: | June 1, 2001 |
| Device Trade Name: | Palomar LC100 |
| Common Name: | Super Long Pulse Diode Laser |
| Classification Name: | Laser surgical instrument for use in General and<br>Plastic Surgery and in Dermatology<br>(see: 21 CFR 878-4810).<br>Product Code: GEX<br>Panel: 79 |
| Legally-Marketed Predicate Device: | |
Palomar SLP 1000 Diode Laser Palomar Medical Technologies, Inc. K994225; K010580
LightSheer Diode Array Laser Star Medical Technologies, Inc. K973324, K974346, K982940, K001746, K003614
System Description:
The LC100 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 - 1000 ms. The corresponding fluence is delivered through a 12x12 or 12x6 mm handpiece
{1}------------------------------------------------
tip. The laser pulses are generated at a maximum pulse repetition frequency of 3.3 Hz.
The complete system consists of a, chiller, a footswitch, and a handpiece containing diode bars connected to the power unit with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch is depressed. The handpiece tip is water-Laser cooled to provide active skin cooling. parameters and other system features are controlled from the user interface panel on top of the laser unit, which provides an interface to the system computer.
the legally-marketed claimed predicate device, i.e., the SLP1000™ and LightSheer™ diode lasers.
Intended Use of the Device: The LC100 Diode Laser System is indicated for haire removal, permanent hair reduction, treatment of pigmented and vascular lesions, including leg incision/excision, ablation and veins, and coagulation of soft tissue (for patients with skin types I-VI, including tanned skin). The differences in the specifications of the LC100 Performance Data: laser and the predicate device do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the LC100 Diode Conclusion: Array Laser System is substantially equivalent to
1 Q
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
Palomar Medical Technologies, Inc. c/o Ms. Marcy Moore 131 Kelekent Lane Cary, North Carolina 27511
Re: K011747
Trade/Device Name: Palomar LC100 Regulation Number: 878.4810 Regulatory Class: II Product Code: GEX Dated: May 31, 2001 Received: June 5, 2001
Dear Ms. Moore:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use atoo 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). You may, therefore, market the device, subject to the general controls Contistions of the Act. The general controls provisions of the Act include requirements for annual provisions listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remance rippt of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspootions, the Pood and on may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
## Page 2 - Ms. Marcy Moore
This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and in your ding of substantial equivalence of your device to a legally marketed notification. The I Dr I manage sification 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 and rr you desire specific dain vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 101 ====================================================================================================================================================== (201) 594-1639 - 1057 - 1051 - 1031) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monmation on your responsibility on the Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Sus-Wall-ton M.D.
Fon
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
## INDICATIONS FOR USE STATEMENT
510(K) Number: K011747
Device Name: Palomar LC100
Indications for Use:
The LC100 diode laser system is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as a long-term, stable reduction in the number of re-growing hairs after a treatment regime.
The LC100 is also indicated for photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, hemangioma, spider nevi, and other benign vascular lesions; photothermolysis of blood vessels (treatment of facial and leg veins); removal of benign pigmented lesions, including lentigines, nevi, chloasma, and café-au-lait; incision/excision, ablation and coagulation (homeostasis) of soft tissue.
The LC100 is indicated for use in patients with skin types I-VI, including tanned patients.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
signature
(Division Sign-Off) (Division Sigir Oxx)
Division of General, Restorative Division of Sgical Devices
510(k) Number K011747
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.
