K041930 · Iridex Corporation · GEX · Sep 10, 2004 · General, Plastic Surgery
Device Facts
Record ID
K041930
Device Name
VARILITE LASER SYSTEM
Applicant
Iridex Corporation
Product Code
GEX · General, Plastic Surgery
Decision Date
Sep 10, 2004
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic, 3rd-Party Reviewed
Indications for Use
The VariLite Laser System is intended for use in dermatological applications: The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for: - the treatment of vascular lesions including: Cherry Angiomas -Telangiectasia - Neovascularization Leg Veins - Port Wine Stains - Spider Angiomas Venous Lakes - Roscea - the treatment of benign pigmented lesions including: Freckles Lentigines - Poikloderma of Civatte Dermatosis Papulosis Nigra - Melasma Café- au- lait Stains - the treatment of cutaneous lesions including: Keratoses -Verruca - Skin Tags - the treatment of moderate inflammatory acne vulgaris. The 940 nm wavelength delivered with VariLite handpieces is indicated for: - the treatment of vascular lesions including: Cherry Angiomas Telangiectasia -. Neovascularization Leg Veins t Port Wine Stains Spider Angiomas - -Roscea - the treatment of benign pigmented lesions including: Lentigines - Dermatosis Papulosis Nigra - Café- au- lait Stains - hair removal .
Device Story
VariLite is a dual-wavelength (532 nm and 940 nm) medical diode laser system. Components include a laser console, footswitch, and fiber optic handpieces (manual or ScanLite Scanner). Used in clinical dermatology settings by physicians to treat vascular, pigmented, and cutaneous lesions, acne vulgaris, and for hair removal. Laser energy is delivered to the target tissue via handpieces; clinical effect is based on photothermal interaction with target chromophores. Output is controlled by the operator via the console interface. Benefits include non-invasive treatment of various skin conditions. The system is compatible with previously cleared DioLite 532 handpieces.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on non-clinical performance testing to applicable consensus and voluntary standards.
Technological Characteristics
Dual-wavelength diode laser system (532 nm and 940 nm). Components: laser console, footswitch, fiber optic handpieces (manual and ScanLite Scanner). Connectivity: compatible with existing DioLite 532 handpieces. Energy source: electrical power to diode laser. Sterilization: not specified (assumed standard for laser handpieces).
Indications for Use
Indicated for dermatological treatment of vascular lesions (telangiectasia, cherry angiomas, leg veins, neovascularization, spider angiomas, port wine stains, rosacea, venous lakes), benign pigmented lesions (lentigines, freckles, dermatosis papulosis nigra, poikiloderma of Civatte, café-au-lait stains, melasma), cutaneous lesions (keratoses, verruca, skin tags), moderate inflammatory acne vulgaris, and hair removal.
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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04 1930 1/3
# 510(k) Summary IRIDEX Corporation VariLite Laser System
# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
John Jossy IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 (650) 962-8848 ext. 3016
SEP 1 0 2004
Contact Person: (same as above)
Date Prepared: May 27, 2004
#### Name of Device and Name/Address of Sponsor
VariLite Laser System
IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
## Classification Name
Laser Instrument, Surgical, Powered CFR Section: 878.4810 Product Code: GEX
### Predicate Devices
The VariLite Laser System (VariLitc) is substantially equivalent to other currently legally marketed dermatology laser devices including those in the following table:
| Name | Manufacturer | 510(k) # |
|-----------------------|--------------------|------------------|
| DioLite 532 | IRIDEX Corporation | K964074 |
| Aura | Laserscope | K951034 /K024206 |
| Prima KTP | Nidek, Inc. | K973828 |
| Medilas D SkinPulse S | Dornier MedTech | K003993 |
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K041930 2/3
### Device Description
The VariLite is a dual wavelength medical diode laser source that delivers laser light at either 532 nm or 940 nm. Its main components are a laser console, footswitch, and a variety of fiber optic handpiece delivery devices, including manual handpieces and the ScanLite Scanner, which are all considered part of the VariLite Laser System. The VariLite console is also intended to be compatible with other delivery devices that have been the subject of previous 510(k) applications. These devices include DioLite 532 handpieces (K964074).
#### Intended Use/Indications for Use
The VariLite is intended for use in dermatological applications: The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for:
- the treatment of vascular lesions including: .
- Telangiectasia Cherry Angiomas - -Leg Veins Neovascularization - -Spider Angiomas Port Wine Stains -ﺳ -Roscea -Venous Lakes the treatment of benign pigmented lesions including: . Lentigines Freckles --Dermatosis Papulosis Nigra Poikloderma of Civatte -- Café- au- lait Stains -Melasma the treatment of cutaneous lesions including: . Verruca Keratoses ー -
- Skin Tags -
.
.
- the treatment of moderate inflammatory acne vulgaris. .
The 940 nm wavelength delivered with VariLite handpieces is indicated for:
- the treatment of vascular lesions including: Telangiectasia Cherry Angiomas --Leg Veins ﯩ Neovascularization -Spider Angiomas -Port Wine Stains -Roscea Venous Lakes ・ the treatment of benign pigmented lesions including: Lentigines --Freckles Dermatosis Papulosis Nigra Poikloderma of Civatte ---Café- au- lait Stains -Melasma
- hair removal .
#### Technological Characteristics and Substantial Equivalence
The VariLite is a dual wavelength diode laser which delivers laser light at the wavelengths of 532 nm and 940 nm.
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K041930 3/3
The IRIDEX Corporation DioLite 532 delivers a wavelength of 532 nm and is indicated for the treatment of vascular and pigmented lesions. Thus, it delivers the same wavelength and has similar indications to those of the VariLite.
The Laserscope Aura delivers laser light at a wavelength of 532 nm and is indicated for the treatment of vascular and pigmented lesions; for the treatment of cutaneous lesions: and for the treatment of acne vulgaris. Thus, it delivers the same wavelength and has similar indications to those of the VariLite.
The Nidek. Inc Prima KTP delivers laser light at a wavelength 532 nm and is indicated for the treatment of vascular and pigmented lesions and the treatment cutaneous lesions. Thus it delivers the same wavelength and has similar indications to those of the VariLite.
The Dornier MedTcch Medilas D SkinPulse S delivers laser light at a wavelength of 940 nm. It is indicated for the treatment of vascular and pigmented skin lesions and for hair removal. Thus it delivers the same infrared wavelength and has similar indications to those of the VariLite.
#### Non-Clinical performance Data
Non-clinical performance testing to applicable consensus and voluntary standards is demonstrated via a Declaration of Conformity.
### Clinical performance Data
Nonc
#### Conclusion
The VariLite is substantially equivalent to predicate devices currently legally marketed for the intended use/indications for use above.
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Image /page/3/Picture/2 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2004
Iridex Corporation c/o Mr. Daniel W. Lehtonen Staff Engineer – Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K041930
Trade/Device Name: VariLite Laser System 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: August 26, 2004 Received: August 27, 2004
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave rowled your your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreations of the enactment date of the Medical Device Amendments, or to conimered pror to ria) 2011-07-12, 2017 11:25 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 r ou may aller 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 classified (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 or any i 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 - Mr. Daniel W. Lehtonen
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter with and on. The FDA finding of substantial equivalence of your device to a legally premantee nevice 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 it four attails office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marc Sacturers, International and Consumer 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,
Miriam C. Provost
C.S. - M.S. - Ph.D.
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
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# INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K041930
Device Name: IRIDEX VarilLite Laser System____________________________________________________________________________________________________________________________________
Indications For Use:
.
-
The VariLite Laser System is intended for use in dermatological applications:
The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for:
- the treatment of vascular lesions including: ●
- Cherry Angiomas -Telangiectasia -
- Neovascularization ﮯ Leg Veins
- Port Wine Stains -
- Spider Angiomas Venous Lakes -
- Roscea ー the treatment of benign pigmented lesions including: .
- Freckles Lentigines --
- Poikloderma of Civatte Dennatosis Papulosis Nigra
- -Melasma Café- au- lait Stains ﺘ
- the treatment of cutaneous lesions including: .
- Keratoses -Verruca -
- Skin Tags -
- the treatment of moderate inflammatory acne vulgaris. .
The 940 nm wavelength delivered with VariLite handpieces is indicated for:
- the treatment of vascular lesions including: .
- Cherry Angiomas Telangiectasia -.
- Neovascularization Leg Veins t
- Port Wine Stains Spider Angiomas
- -Roscea ・
- the treatment of benign pigmented lesions including: .
- Lentigines -
- Dermatosis Papulosis Nigra -
- Café- au- lait Stains -
- hair removal .
Prescription Use _____________________________________________________________________________________________________________________________________________________________
-
OR (Per 21 CFR 801.109)
-
-
Over-The-Counter Use - - -
luation (ODE)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Venous Lakes
Poikloderma of Civatte
Freckles
Melasma
Concurrent
(Division Sign-Out)
Division of General, Restorative. and Neurological Devices
510(k) Number Kot/ 930
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.
