K123777 · Ultralight Laser Technologies, LLC · GEX · Apr 11, 2013 · General, Plastic Surgery
Device Facts
Record ID
K123777
Device Name
MULTILASER SYSTEM
Applicant
Ultralight Laser Technologies, LLC
Product Code
GEX · General, Plastic Surgery
Decision Date
Apr 11, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery). The Nd:YAG handpiece is indicated for: At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair. At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes). The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for: Hair Removal, Permanent hair reduction, Treatment of vascular lesions, Treatment of benign pigmented lesions, Treatment of Leg Veins, Treatment for pseudofolliculitis barbae. The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications: Hair Removal (650nm filter), Permanent hair reduction (650nm filter), Treatment of vascular lesions (510nm filter), Treatment of benign pigmented lesions (510 nm filter), Mild to Moderate inflammatory acne (450nm filter).
Device Story
MultiLaser System is a console-based surgical laser platform featuring four interchangeable handpieces: Er:YAG, Nd:YAG, Diode, and IPL. The console houses power supply, control electronics, and user interface. The system delivers light energy to target skin tissues for ablation, coagulation, vaporization, or cutting. Operated by physicians in clinical settings (dermatology/plastic surgery), the device allows practitioners to select specific wavelengths and pulse parameters via the console to treat various dermatological conditions, including tattoos, vascular lesions, and unwanted hair. The output is controlled by the clinician to achieve therapeutic thermal effects on the skin, potentially benefiting patients by improving skin appearance, removing unwanted hair, or treating specific vascular/pigmented lesions.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Console-based system with four handpieces: Er:YAG (2940nm), Nd:YAG (1064nm/532nm), Diode (810nm), and IPL (450-1200nm). Energy delivery via light guide or direct beam. Features include variable pulse widths, repetition rates (1-5Hz for Nd:YAG, up to 10Hz for Er:YAG), and multiple spot sizes. Aiming beam provided by HeNe laser. System is powered, class II surgical instrument.
Indications for Use
Indicated for dermatology and plastic surgery patients requiring soft tissue ablation, coagulation, or vaporization; tattoo removal; hair removal/reduction; treatment of vascular lesions (veins, angiomas, port wine stains); treatment of benign pigmented lesions; and treatment of mild to moderate inflammatory acne. Applicable to Fitzpatrick Skin Types I-VI (Diode) or I-IV (IPL).
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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#### Attachment 5 510(K) Summary as required by section 807.92(c). MultiLaser System
ﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ
ﻴﺔ
# This 510(K) Summary of safety and effectiveness for the MultiLaser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary. UltraLight Laser Technologies, LLC Applicant: UltraLight Laser Technologies LLC 105 Citation Court
Contact Person:
Telephone: Fax: Email:
K123777
Address:
Preparation Date:
Device Trade Name:
Common Name:
Classification Name:
Classification
Legally Marketed Predicate Device(s):
Description of the MultiLaser System:
Intended use of the MultiLaser System
The MultiLaser System consists of a console that houses the power supply, control electronics and user interface and four separate handpiece. The four handpieces consist of an Er:YAG laser handpiece, an Nd:YAG laser handpiece, a Diode laser handpiece and an IPL handpiece.
The Er: YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The Nd:YAG handpiece is indicated for:
- At the 1064 nm wavelength dark ink tattoo . removal, removal of pigmented lesions and the removal or lightening of hair.
- At the 532 nm wavelength removal of red ink . tattoos, treatment of vascular lesions including facial
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Page 1 of 4
Mr. Mark Rohrer
1-205-356-1172 1-205-356-1171 ssmed@bellsouth.net
Birmingham, AL 35209
November 30, 2012
MultiLaser System
Laser
Instrument, Surgical, Powered, laser GEX, 21 CFR 878.4810
Powered light based non-laser surgical instrument with thermal effect ONF, 21 CFR 878.4810
TriPlex Laser System (K)110502 Apex Laser System (K)110304 Cheveux Laser System (K)100893
Class II
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# Attachment 5
# 510(K) Summary as required by section 807.92(c).
MultiLaser System
#### Page 2 of 4
and leq veins. telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)
The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for:
- . Hair Removal
- . Permanent hair reduction
- Treatment of vascular lesions .
- . Treatment of benign pigmented lesions
- . Treatment of Leg Veins
- . Treatment for pseudofolliculitis barbae
The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale following . for the indications:
- Hair Removal .
- (650nm filter)
- Permanent hair reduction . (650nm filter)
- . Treatment of vascular lesions (510nm filter)
- . Treatment of benign pigmented lesions (510 nm filter)
- . Mild to Moderate inflammatory acne (450nm filter)
Performance Data:
None
None
Results of Clinical Study:
Technical Specifications Comparison:
K123777
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## Attachment 5 510(K) Summary as required by section 807.92(c). MultiLaser System
K123777
ﮯ ،
Nd:YAG Handpiece Specification
Page 3 of 4
| | UltraLight LLC Multi-Laser System | Sandstone Medical Technologies<br>LLC TriPlex (K110502) |
|-----------------|------------------------------------------------------|---------------------------------------------------------|
| Energy | Up to 1000mJ | Up to 1000mJ |
| Maximum Fluence | 12J/cm2 | 12J/cm2 |
| Wavelength | 1064nm and 532nm | 1064nm and 532nm |
| Spot Size | up to 5mm | up to 5mm |
| Pulse Width | 10ns | 10ns |
| Pulsewidth | Single pulse and variable . 0.06 sec<br>- continuous | Single pulse and variable . 0.06 sec<br>- continuous |
| Repetition Rate | 1-5Hz | 1-5Hz |
| Aiming Beam | HeNe | HeNe |
Diode Laser Handpiece Specification
| | UltraLight LLC Multi-Laser<br>System | Sandstone Medical<br>Technologies LLC<br>Cheveux (K100893) |
|----------------------|--------------------------------------|------------------------------------------------------------|
| Light Source | Diode Array | Diode Array |
| Wavelength | 810nm | 810nm |
| Energy Density | Up to 100J/cm² | Up to 100J/cm² |
| Spot Size | 14x 10 mm | 14x 10 mm |
| Pulse Width | Up to 400ms | Up to 400ms |
| Beam Delivery System | Light Guide | Light Guide |
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### Attachment 5 510(K) Summary as required by section 807.92(c). MultiLaser System
## K123777
Page 4 of 4
#### Er:YAG Laser Handpiece Specification
| | UltraLight LLC Multi-Laser<br>System | Sandstone Medical<br>Technologies LLC TriPlex<br>(K110502) |
|-----------------|--------------------------------------|------------------------------------------------------------|
| Wavelength | 2940nm | 2940nm |
| Max Power | 2.4 W | 2.4 W |
| Max Fluence | 8 J/cm2 | 8 J/cm2 |
| Pulse Width | 300 μs | 300 μs |
| Repetition Rate | Up to 10 pulse per second | Up to 10 pulse per second |
| Spot Size | 1.5mm, 3mm, 6mm, 9mm | 1.5mm, 3mm, 6mm, 9mm |
## Intense Pulsed Light (IPL) Handpiece Specification
| | UltraLight LLC Multi-Laser<br>System | Sandstone Medical<br>Technologies LLC Apex<br>(K110304) |
|--------------------|--------------------------------------|---------------------------------------------------------|
| Light Source | Pulsed Incoherent Light | Pulsed Incoherent Light |
| Max Fluence | Up to 35J/cm² | Up to 35J/cm² |
| Wavelength | 450 - 1200 nm | 450 - 1200 nm |
| Spot Size | 35 x 15 mm² | 35 x 15 mm² |
| Pulse Width | Up to 200ms | Up to 200ms |
| Beam Delivery Stem | Light Guide | Light Guide |
Conclusion:
The MultiLaser System is substantially equivalent to other existing laser and IPL systems in commercial distribution for use in Dermatology and Plastic Surgery.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
UltraLight Laser Technologies, LLC % Mr. Mark Rohrer 105 Citation Court Birmingham, Alabama 35209
April 11, 2013
Re: K123777
Trade/Device Name: MultiLaser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: February 21, 2013 Received: March 11, 2013
Dear Mr. Rohrer:
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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Page 2 – Mr. Mark Rohrer
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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, FOR
PeterD.Rumm-S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): K123777
Multi-Laser Laser System Device Name:
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The Nd:YAG handpiece is indicated for:
- At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented . lesions and the removal or lightening of hair.
- At the 532 nm wavelength removal of red ink tattoos, treatment of vascular . lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)
The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for:
- Hair Removal .
- Permanent hair reduction ●
- Treatment of vascular lesions .
- · · Treatment of benign pigmented lesions
- . Treatment of Leg Veins
- Treatment for pseudofolliculitis barbae ●
Neil R Ogdens // 0 10 11:21 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123777
{7}------------------------------------------------
The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:
- Hair Removal .
- Permanent hair reduction .
- . Treatment of vascular lesions
- Treatment of benign pigmented lesions .
- Mild to Moderate inflammatory acne .
(650nm filter) (650nm filter) (510nm filter) (510 nm filter) (450nm filter)
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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 Ogder 2013.04.10 10:14:45 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123777
Page 2 of 2
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.
