K112505 · Regulatory Insight, Inc. · GEX · Apr 6, 2012 · General, Plastic Surgery
Device Facts
Record ID
K112505
Device Name
ETHEREA
Applicant
Regulatory Insight, Inc.
Product Code
GEX · General, Plastic Surgery
Decision Date
Apr 6, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Intense Pulsed Light (IPL-sq) - Treatment mild to moderated inflammatory and pustular inflammatory acne vulgaris. (400nm and 640nm filters) - The treatment of benign pigmented epidermal lesions including dyschromias, hyperpigmentation, melasma and ephelides (freckles). (540nm and 580nm filters) - Lentigines, nevi, and café-au-lait macules. (540nm filter) - The treatment of cutaneous lesions including warts, scars and striae. (scars and striae - 540nm, 580nm and 640 filters) (warts - 540nm and 580 filters) - 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, and venous malformations. (540nm and 580nm filters) - The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction. (580nm and 640nm filters) Infrared (Intense IR) Topical heating for the purpose of elevating tissue's temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase of local circulation where applied, and the relaxation of muscles. In addition, may also help muscle spasms, minor sprains and strains, and minor muscular back pain. Laser Nd:Yag 1064nm (1064 LongPulse) - Coagulation and hemostasis of vascular lesions and epidermal tissue, including the treatment of superficial and deep telangiectasias, reticular veins (0,1- 4 mm diameter) of the leg, rosacea, warts, venous lake, leg veins, poikiloderma of Civatte, angiomas, hemangiomas, and nevus; - Non ablative treatment of facial wrinkles, scars and striae; - The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction; - Treatment of pseudofolliculitis barbae.
Device Story
Etherea is a multi-application laser and light-based system for dermatology and aesthetic procedures. Device utilizes Intense Pulsed Light (IPL-sq), Infrared (Intense IR), and Nd:Yag 1064nm laser modules. Inputs include user-selected wavelengths via interchangeable filters (400-640nm for IPL) and laser energy parameters. System transforms electrical energy into specific light/laser outputs applied to skin or tissue. Operated by clinicians in clinical settings. IPL/Laser outputs target chromophores (melanin, hemoglobin, water) for coagulation, hemostasis, hair reduction, or tissue heating. Infrared module provides topical heating for pain relief and muscle relaxation. Output affects clinical decision-making by enabling non-invasive treatment of vascular/pigmented lesions, hair removal, and musculoskeletal pain management. Benefits include reduced lesion appearance, permanent hair reduction, and temporary pain relief.
Clinical Evidence
No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed devices.
Technological Characteristics
Multi-modal system featuring IPL-sq, Infrared, and Nd:Yag 1064nm laser. IPL uses interchangeable filters (400nm, 540nm, 580nm, 640nm) to target specific chromophores. Nd:Yag 1064nm laser provides long-pulse coagulation and hemostasis. Infrared module provides thermal energy for tissue heating. System is a laser surgical instrument (21 CFR 878.4810).
Indications for Use
Indicated for patients requiring dermatological laser/light therapy for acne, pigmented/vascular lesions, hair removal, scar/striae treatment, and wrinkle reduction; also indicated for patients requiring topical heating for relief of minor muscle/joint pain, stiffness, spasms, and increased local circulation.
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.
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Regulatory Insight, Incorporated % Mr. Kevin Walls 5401 S. Cottonwood Court Greenwood Village, Colorado 80121
JUL 1 3 2012
Re: K112505
Trade/Device Name: Etherea 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, ONF, ILY Dated: March 27, 2012 Received: March 28, 2012
Dear Mr. Walls:
This letter corrects our substantially equivalent letter of April 6, 2012.
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 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
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Page 2 - Mr. Kevin Walls.
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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Richard D. Lyons
FOR Mark N. 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): K112505
Device Name: Etherea
Indications for Use:
## Intense Pulsed Light (IPL-sq)
- Treatment mild to moderated inflammatory and pustular inflammatory acne > vulgaris.
- (400nm and 640nm filters)
- > The treatment of benign pigmented epidermal lesions including dyschromias, hyperpigmentation, melasma and ephelides (freckles). (540nm and 580nm filters)
- V Lentigines, nevi, and café-au-lait macules. (540nm filter)
- > The treatment of cutaneous lesions including warts, scars and striae. (scars and striae - 540nm, 580nm and 640 filters) (warts - 540nm and 580 filters)
- > 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, and venous malformations.
- (540nm and 580nm filters)
- > The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction.
(580nm and 640nm filters)
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
Neil R.P. Ogden for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112505
Page 1 of 2
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### Indications for Use
## 510(k) Number (if known): K112505
Device Name: Etherea
Indications for Use:
### Infrared (Intense IR)
Topical heating for the purpose of elevating tissue's temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase of local circulation where applied, and the relaxation of muscles. In addition, may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
# Laser Nd:Yag 1064nm (1064 LongPulse)
- Coagulation and hemostasis of vascular lesions and epidermal tissue, including the treatment of superficial and deep telangiectasias, reticular veins (0,1- 4 mm diameter) of the leg, rosacea, warts, venous lake, leg veins, poikiloderma of Civatte, angiomas, hemangiomas, and nevus;
- > Non ablative treatment of facial wrinkles, scars and striae;
- > The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction;
- > Treatment of pseudofolliculitis barbae.
Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (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)
Neil R. Oade for mkm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
112505 · 510(k) Number_ 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.
