K060448 · Lumenis, Ltd. · GEX · Jul 6, 2006 · General, Plastic Surgery
Device Facts
Record ID
K060448
Device Name
LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.
Applicant
Lumenis, Ltd.
Product Code
GEX · General, Plastic Surgery
Decision Date
Jul 6, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or laser and/or RF energy) is indicated for use in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows: The 515-1200 nm intense pulsed light wavelengths are indicated for: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of tattoos; The treatment of cutaneous lesions, including warts, scars and striae; The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles. The 1064 nm wavelength produced by the Nd: YAG laser is indicated for: The coagulation and hemostasis of vascular lesions and soft tissue, including: Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg: The removal of unwanted hair from all skin types, and 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. The 800 nm wavelength produced by the LightSheer diode laser is indicated for: The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles; The treatment of vascular lesions, including angiomas, hemangiomas telangiectasia and other benign vascular lesions; The treatment of leg veins; The treatment of benign pigmented lesion; The treatment of pseudofolliculitis barbae; The LightSheer diode laser is intended for use on all skin types (Fitzpatrick skin types 1 - VI), including tanned skin. The Aluma 468 kHz energy is indicated for: The Aluma Skin Renewal System is intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of wrinkles and rhytids.
Device Story
Lumenis One is a multi-modality system for surgical, aesthetic, and cosmetic procedures. Inputs include electrical power transformed into light (IPL, Nd:YAG laser, Diode laser) or RF energy (468 kHz). System comprises a console, control/display unit, and interchangeable delivery handpieces. Integrated skin cooling and safety triggers are included. Operated by physicians in clinical settings. The device targets melanin in hair follicles or vascular/pigmented structures to achieve therapeutic effects (coagulation, hemostasis, hair reduction, skin renewal). Healthcare providers use the console to select treatment parameters based on patient skin type and condition. Output is delivered via handpieces to the patient's skin. Benefits include non-invasive treatment of vascular/pigmented lesions, hair reduction, and wrinkle improvement.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on identical or similar indications for use and technical specifications to legally marketed predicate devices.
Technological Characteristics
Multi-modality system delivering IPL (515-1200 nm), Nd:YAG laser (1064 nm), Diode laser (800 nm), and RF energy (468 kHz). Features system console, control/display, and interchangeable handpieces. Includes integrated skin cooling, trigger buttons, and remote interlock safety mechanisms. Standalone system.
Indications for Use
Indicated for surgical, aesthetic, and cosmetic applications in general/plastic surgery and dermatology. Treats benign pigmented epidermal lesions, tattoos, cutaneous lesions (warts, scars, striae), benign vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, poikiloderma, leg veins), and pseudofolliculitis barbae. Provides hair reduction (all skin types I-VI) and non-ablative facial wrinkle treatment. Prescription use only.
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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### Section 5 510(k) Summary for the Lumenis One Family of Systems -
Lumenis, Inc.
K060448
#### I. General Information
Submitter:
Contact Person:
2400 Condensa Street Santa Clara, CA 95051
Connie Hoy Vice President, Global RA/QA
Lisa Scott Manager, RA/QA
June 30, 2006 Summary Preparation Date:
- II. Names
Device Names: Lumenis One Family of Systems; Lumemis One
Primary Classification Name: Laser Powered Surgical Instrument (and Accessories)
### III. Predicate Devices
- Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: YAG Laser � Systems (K020839, K024093, K030342, K030527);
- LightSheer Pulsed Diode Array Laser System (K973324, K974346, K982940, . K001746, K003614);
- . Aluma Skin Renewal System (K051214);
### IV. Product Description
Lumenis One systems are comprised of the following main components:
- System console; �
- . Control and Display;
- One or more delivery handpieces, the Treatment Heads (up to three attached . out of four handpieces available for each system);
- Skin cooling technology integrated into the handpiece (as applicable); .
- Trigger button integrated into the handpiece; an additional safety button . integrated into the laser handpieces;
- . Remote interlock connector (disables pulse emission when treatment room door is opened).
### V. Indications for Use
The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or RF energy) is indicated for use in surgical. aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows:
510(k) Submission: Lumenis One Family of Systems
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## > Intense Pulsed Light (IPL) Wavelengths (515 - 1200 nm):
The 515-1200 nm intense pulsed light wavelengths are indicated for:
- The treatment of benign pigmented epidermal lesions, including . dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- . The treatment of tattoos:
- The treatment of cutaneous lesions, including warts, scars and striae; .
- The treatment of benign cutaneous vascular lesions, including port . wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- . The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
### > Nd:YAG Laser Wavelength (1064 nm):
The 1064 nm wavelength produced by the Nd: YAG laser is indicated for:
- The coagulation and hemostasis of vascular lesions and soft tissue, . including:
- Treatment and clearance of superficial and deep telangiectasias t (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg:
- The removal of unwanted hair from all skin types, and to effect stable � long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicies;
- . The non-ablative treatment of facial wrinkles.
## > LightSheer Diode Laser Wavelength (800 mm):
The 800 nm wavelength produced by the LightSheer diode laser is indicated for:
- The removal of unwanted hair, and to effect stable long-term, or 0 permanent', hair reduction through selective targeting of melani, in hair follicles;
- The treatment of vascular lesions, including angiomas, hemangiomas � telangiectasia and other benign vascular lesions;
- The treatment of leg veins; .
- The treatment of benign pigmented lesion; .
- The treatment of pseudofolliculitis barbae; .
The LightSheer diode laser is intended for use on all skin types (Fitzpatrick skin types 1 - VI), including tanned skin.
510(k) Submission: Lumenis One Family of Systems
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
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### > Aluma RF Energy (468 kHz):
The Aluma 468 kHz energy is indicated for:
- The Aluma Skin Renewal System is intended for use in Dermatologic and General . Surgical procedures for the non-invasive treatment of wrinkles and thytids.
### VI. Rationale for Substantial Equivalence
The Lumenis One Family of Systems share the same intended uses as the predicate devices-the Lumenis Family of Intense Pulsed-Light (IPL) and IPL Nd: Y A G Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, K974346, K982940, K001746, K003614), and the Aluma Skin Renewal System (K051214), in that they are intended for use for the same surgical, aesthetic and cosmetic applications in general and plastic surgery, and dermatology.
The Lumenis One Family of Systems share indications for use as the predicate devices.
The technical specifications, including the range of treatment parameters, the basic control system, and delivery devices of the Lumenis One Family of Systems are identical or similar to the predicate devices.
### VII. Safety and Effectiveness Information
The Lumenis One Family of Systems share the same indications for use and the same or similar technical specifications as the currently marketed predicate Lumenis Family of Intense Pulsed-Light (IPL) and IPL Nd: Y AG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, K974346, K982940, K001746, K003614), and the Aluma Skin Renewal System (K051214). The small differences that exist in certain technical specifications are not significant and they do not alter the safety or effectiveness of the Lumenis One Family of Systems. Clinical data therefore was not provided.
### VIII. Conclusion
Based on the foregoing, the Lumenis One Family of Systems were found to be substantially equivalent to the predicate devices, Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: Y AG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, K974346. K982940, K001746, K003614), and the Aluma Skin Renewal System (K051214 ), all marketed by Lumenis.
The Lumenis One Family of Systems share indications for use and similar or identical design features, functional features, and technical specifications, and thus are substantially equivalent to, the currently marketed predicate devices.
510(k) Submission: Lumenis One Family of Systems
Section 5 - Page 3
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing to the right, with flowing lines representing hair or clothing. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is written around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2006
Lumenis, Inc. c/o Ms. Martha Murari 2400 Condensa Street Santa Clara, California 95051
Re: K060448 Trade/Device Name: Lumenis One Family of Systems Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Regulatory Class: II Product Code: GEX Dated: May 16, 2006 Received: May 17, 2006
Dear Ms. Martha Murari:
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.
If your device is ciassified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801): 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. Martha Murari
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtained, 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,
Herbert Leuer wo
for
Mark Melkerson 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): K060448
## Device Name: Lumenis One Family of Systems
Indications for Use:
The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or laser and/or RF energy) is indicated for use in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows:
## > Intense Pulsed Light (IPL) Wavelengths (515 - 1200 nm):
The 515-1200 nm intense pulsed light wavelengths are indicated for:
- The treatment of benign pigmented epidermal lesions, including . dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- � The treatment of tattoos;
- The treatment of cutaneous lesions, including warts, scars and striae; �
- . The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiers poss rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- The removal of unwanted hair from all skin types, and to effect stable . long-term, or permanent', hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
### *** Continued on Following Page***
| Prescription Use | <span style="text-decoration: overline;">☑</span> |
|-----------------------------|---------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | |
AND/OR
| Over-The-Counter Use | <span style="text-decoration: overline;">☐</span> |
|------------------------|---------------------------------------------------|
| (21 CFR 801 Subpart C) | |
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|
| (Division Sign-Off) |
|---------------------|
|---------------------|
| Division of General, Restorative, | Page _1_ of _2_ |
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| and Neurological Devices | |
<sup>1</sup> Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
| 510(k) Number | k060448 |
|---------------|---------|
|---------------|---------|
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## > Nd:YAG Laser Wavelength (1064 nm):
The 1064 nm wavelength produced by the Nd: YAG laser is indicated for:
- The coagulation and hemostasis of vascular lesions and soft tissue, . including:
- Treatment and clearance of superficial and deep telangiectasias ، (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg:
- The removal of unwanted hair from all skin types, and 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. .
## > LightSheer Diode Laser Wavelength (800 nm):
The 800 nm wavelength produced by the LightSheer diode laser is indicated for:
- The removal of unwanted hair, and to effect stable long-term, or . permanent', hair reduction through selective targeting of melanin in hair follicles:
- The treatment of vascular lesions, including angiomas, hemangiomas . telangiectasia and other benign vascular lesions;
- The treatment of leg veins; .
- The treatment of benign pigmented lesion; .
The treatment of pseudofolliculitis barbae; ●
The LightSheer diode laser is intended for use on all skin types (Fitzpatrick skin types 1 - VI), including tanned skin.
### A Aluma RF Energy (468 kHz):
The Aluma 468 kHz energy is indicated for:
- The Aluma Skin Renewal System is intended for use in Dermatologic and General . Surgical procedures for the non-invasive treatment of wrinkles and thytids.
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> <span style="border: 1px solid black;">☒</span> |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------|
|-------------------------------------------------|---------------------------------------------------------------------------------------------------|
AND/OR
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | <span style="text-decoration: overline;"> </span> <span style="border: 1px solid black;">☐</span> |
|------------------------------------------------|---------------------------------------------------------------------------------------------------|
|------------------------------------------------|---------------------------------------------------------------------------------------------------|
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 2 of 2 Division of Gener and Neurological 510(k) Number
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.
