K053324 · Chromogenex Plc · GEX · Jan 5, 2006 · General, Plastic Surgery
Device Facts
Record ID
K053324
Device Name
CHROMOLITE SYSTEM
Applicant
Chromogenex Plc
Product Code
GEX · General, Plastic Surgery
Decision Date
Jan 5, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic, 3rd-Party Reviewed
Indications for Use
The Chromolite™ System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialities of plastic surgery and dermatology as follows: The treatment of moderate inflammatory acne vulgaris . The treatment of benign pigmented epidermal lesions . including dyschromia, hyper-pigmentation, melasma, ephelides (freckles) 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 leq telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-. term or permanent hair reduction.
Device Story
Chromolite System is an Intense Pulsed Light (IPL) device; utilizes xenon flashlamp technology to deliver light-based therapy. Emits light at 390nm–1200nm via 50mm x 15mm waveguide; repetition rate 0.5Hz. Used in clinical settings by medical professionals (plastic surgery/dermatology) for selective photothermolysis, photocoagulation, and hemostasis. Device illuminates dermis to treat acne, pigmented/vascular lesions, cutaneous lesions, and unwanted hair. Healthcare provider operates device to target specific tissue; output is light energy; clinical decision-making based on visual assessment of skin condition. Benefits include non-invasive treatment of aesthetic/cosmetic conditions and long-term hair reduction.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Intense Pulsed Light (IPL) system; xenon flashlamp technology; 390nm–1200nm wavelength range; 50mm x 15mm waveguide; 0.5Hz repetition rate. Complies with European Medical Directive 93/42/EEC and UL60601-1:1996.
Indications for Use
Indicated for Fitzpatrick skin types I-V for treatment of moderate inflammatory acne vulgaris, benign pigmented epidermal lesions (dyschromia, hyper-pigmentation, melasma, ephelides), cutaneous lesions (warts, scars, striae), benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins, venous malformations), and permanent hair reduction.
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.
Predicate Devices
Orion lasers, Lovely system II (Harmony) (K033946)
Submission Summary (Full Text)
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| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chromolite™ System | |
| 510(k) Number K 053324 | |
| Applicant: | Chromogenex Plc. |
| Address: | Units 1 & 2 Heol Rhosyn<br>Parc Dafen<br>Llanelli<br>Carmarthenshire<br>S. Wales<br>SA14 8QG<br>UK |
| Contact Person: | Mr. Chris Williams, Product Development Director |
| Telephone: | +44 (0) 1554 755444 |
| Fax: | +44 (0) 1554 755333 |
| Date prepared: | July 2005 |
| Device Trade Name: | Chromolite™ System |
| Common Name: | Intense Pulsed Light (IPL) |
| Classification Name: | Laser Surgical Instrument 21 C.F.R § 878.4810. |
| Product Classification: | Class II device. |
| Product Code: | GEX |
| Legally Marketed Predicate Device: | The Chromolite™ System is substantially equivalent in terms of<br>technological characteristics, performance, intended use,<br>indications for use and operator interface to;<br><br>• Orion lasers, Lovely system II (Harmony) (K033946) |
| System Description: | The Chromolite™ is a Intense Pulsed Light-based medical device<br>utilising xenon flashlamp technology to illuminate the dermis to<br>offer light based therapies as listed in the indications of use. The<br>Chromolite™ emits light at 390nm to 1200nm via a 50mm x 15mm<br>waveguide at a repetition rate of 0.5Hz. |
| Performance Standards: | The device complies with the European Medical Directive<br>93/42/EEC concerning medical devices, and will comply with<br>voluntary standards UL60601-1:1996 when marketed in the U.S. |
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K0 53324 2/2
- Indications for use: The Chromolite™ System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:
- The treatment of moderate inflammatory acne vulgaris .
- The treatment of benign pigmented epidermal lesions . including dyschromia, hyper-pigmentation, melasma, ephelides (freckles)
- 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 leq telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
- The removal of unwanted hair and to effect stable long-. term or permanent hair reduction.
1 = Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment reqimen.
- Conclusion: The Chromolite system is substantially equivalent to its predicate device cited above, and raises no new safety and/or efficacy issues.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 JAN 5
Chromogenex Plc c/o Marc M. Mouser Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, Washington 98607
Re: K053324
Trade/Device Name: Chromolite System Regulation Number: 21 CFR 878.4810 Regulation Name: 21 CFX 078-1010
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 21, 2005 Received: December 22, 2005
Dear Mr. Mouser:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section >10(x) prematice names in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard mannent date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encentance with the provisions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not requent appro to the general controls provisions of the Act. The 1 ou may, dicierole, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 IT your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations with may be subject to sach additions. Title 21, Parts 800 to 898. In addition. FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 losaanse over device complies with other requirements of the Act that 117A has made a determinations administered by other Federal agencies. You must of any it cachar statutes and regulations and limited to: registration and listing (21 comply with an the Fer 816 creations)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It I art 607), laboring (27 OFF regulation (21 CFR Part 820); and if applicable, the electronic torth in the quanty systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Marc M. Mouser
This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you'ls ough mating of substantial equivalence of your device to a legally prematics notification: 11.0 12.01.2017 11:20:53 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 If you desire specific advice for Jour as 101) 276-0115. Also, please note the regulation entitled, comater the Oriece of Companise notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## chror
## Indications for Use
510(k) Number (if known):
Device Name: Chromolite system
Indications for Use for Fitzpatrick skin types (I to V)
- The treatment of moderate inflammatory acne vulgaris .
- The treatment of benign pigmented epidermal lesions including dyschromia, . hyperpigmentation, melasma, ephelides (freckles)
- 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, erythema of rosacea, nomangiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
- The removal of unwanted hair and to effect stable long-term or permanent hair . reduction.
1 = Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | x |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(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
Page 1 of
(Division Sign-Of Division of General, Restorative, and Neurological De
510(k) Number K053324
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.
