K083733 · Lumenis, Ltd. · GEX · May 4, 2009 · General, Plastic Surgery
Device Facts
Record ID
K083733
Device Name
LUME 2 SYSTEM, MODEL GA0005000
Applicant
Lumenis, Ltd.
Product Code
GEX · General, Plastic Surgery
Decision Date
May 4, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Lume 2, with Intense Pulsed Light ( IPL) wavelengths 515-1200 nm, is indicated for the treatment of: Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos. Cutaneous lesions, including warts, scars and striae. Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, and For the removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles. with Nd:YAG laser at wavelength 1064 nm, is indicated for: The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg The removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles. The non-ablative treatment of facial wrinkles.
Device Story
Lume 2 is a computer-controlled, multi-functional platform utilizing Intense Pulsed Light (IPL) and Nd:YAG laser technologies. System console connects to either Universal IPL or Multi-Spot Nd:YAG treatment heads via flexible umbilical cable. Umbilical houses power, electrical wiring for thermoelectric cooling, and deionized water circulation for flashlamp/laser head cooling. Energy delivered in pulse sequences for controlled emission. Operated by clinicians in clinical settings. Device provides light/laser energy to target melanin in hair follicles or vascular/cutaneous lesions. Output affects clinical decision-making by enabling non-ablative skin treatments, hair reduction, and coagulation of vascular structures. Benefits include stable long-term hair reduction and clearance of various dermatological lesions.
Clinical Evidence
Bench testing, including safety, performance, and functional testing, was conducted to determine substantial equivalence. No clinical study data provided.
Technological Characteristics
Multi-functional platform; IPL (515-1200 nm) and Nd:YAG laser (1064 nm) sources; computer-controlled; thermoelectric (TE) cooling; deionized water cooling system; flexible umbilical cable delivery; pulse sequence energy delivery.
Indications for Use
Indicated for treatment of benign epidermal/cutaneous lesions, vascular lesions, and unwanted hair removal in all skin types (permanent hair reduction in skin types I-V). Nd:YAG laser indicated for vascular lesion coagulation/hemostasis, hair removal, and non-ablative facial wrinkle treatment.
Regulatory Classification
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is accordance with the requirements of SMDA 1990.
#### A. SUBMITTER INFORMATION:
Submitter's Name: Address:
Contact: Phone: Fax: Date of Preparation: Frances E. Harrison 770-630-3281 801-656-2627
December 15, 2008
3959 West 1820 South Salt Lake City, UT 84104
Lumenis, Inc.
B. DEVICE NAME:
> Trade Name(s): Common/Usual Name: Classification Names:
CFR Reference:
Lume 2 System Laser instrument, surgical, powered 79 GEX, Laser Powered Surgical Instrument
21 CFR 878.4810, Laser surgical instrument for use in general and plastic surgery and in dermatology
KOX3733
### C. Predicate device:
Lumenis One Family of Systems (K060448)
### D. DEVICE DESCRIPTION:
The Lume 2 system is a multi-functional platform, computer controlled system which incorporates two technologies and two treatment heads: Intense Pulsed Light (IPL), and Nd:YAG Laser.
The Lume 2 console has a single treatment head connection port that accommodates either the Universal IPL or the Multi-Spot Nd: YAG treatment head.
The treatment heads are attached to the head connector via a flexible cable (umbilical). During operation, deionized water circulates from the system console through the umbilical cable to the treatment heads to cool the flashlamp assembly and/ or the laser head, and the umbilical cable also houses the power cable to provide energy to the light/laser emission and the electrical wiring to power the thermoelectric (TE) cooler. The energy is delivered in pulse sequences, to allow better control.
The principles of operation and fundamental scientific technology are the same for the subject devices and predicate device.
### E. Intended Use:
The Lume 2, with Intense Pulsed Light ( IPL) wavelengths 515-1200 nm, is indicated for the treatment of:
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Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos.
Cutaneous lesions, including warts, scars and striae.
Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, and
For the removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
with Nd:YAG laser at wavelength 1064 nm, is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
The removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The non-ablative treatment of facial wrinkles.
1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
#### u. TECHNOLOGICAL CHARACTERISTICS SUMMARY AND SUBSTANTIAL EQUIVALENCE STATEMENT:
The subject device, the Lume 2 system, has the same intended use, general design and fundamental scientific technology as the predicate device (K060448),
The Lume 2 system uses technology substantially equivalent to the Lumenis One Family of Systems (K060448). There are no new hazards introduced by the Lume 2 System as compared with the predicate devices.
## G. Performance Data Summary:
The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Lume 2 system has been conducted.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
MAY - 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lumenis, Ltd. % Ms. Frances E. Harrison Global VP, Regulatory Affairs/ Quality Compliance 3959 West 1820 South Salt Lake City, Utah 84104
Re: K083733
Trade/Device Name: Lume 2 Intense Pulsed Light & Laser System and delivery devices Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II Product Code: GEX Dated: April 1, 2009 Received: April 3, 2009
# Dear Ms. Harrison:
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 be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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# Page 2 - Ms. Frances E. Harrison
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Center for Devices and Radiological Health
For Volo
Mark N. Melkerson
Director
Der D.n
Division of Surgical, Orthopedic,
and Restorative Devices
Office of Device Evaluation
Enclosure
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### 1.3 Indications for Use Statement
510(k) Number (if known): _ KO83733
Device Name: Lume 2 Intense Pulsed Light & Laser System and delivery devices
Indications for Use:
The Lume 2, with Intense Pulsed Light ( IPL) wavelengths 515-1200 nm, is indicated for the treatment of:
Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos.
Cutaneous lesions, including warts, scars and striae.
Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, and
For the removal of unwanted hair from all skin types, an to effect stable long term, or permanent1 hair reduction in skin types 1-V through selective targeting of melanin in hair follicles.
with Nd: YAG laser at wavelength 1064 nm, is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1- 4.0 mm. diameter) of the leg
The removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The non-ablative treatment of facial wrinkles.
1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
-Neil R. Ogden Firmxm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083733
- 9 -
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.
