K983100 · Kavo America · GEX · Jan 27, 1999 · General, Plastic Surgery
Device Facts
Record ID
K983100
Device Name
KAVO KEY LASER 1242
Applicant
Kavo America
Product Code
GEX · General, Plastic Surgery
Decision Date
Jan 27, 1999
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The KaVo KEY Laser 1242 is intended for the incision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following: Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) Incision for drainage of abscesses Frenectorny, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectomy in the case of hyperplasias of the gingiva or excision of hyperplasias Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papillomas, fibromatoses, benign growths Removal of diseased or inflamed tissue in the periodontal pocket (sulcular debridement) KaVo proposes that the KaVo KE Y Laser 1242 be labeled as a prescription device. This labeling will be included in manuals and other information distributed in the United States.
Device Story
KaVo KEY Laser 1242 is an Erbium:YAG surgical laser; operates at 2.94 microns wavelength; delivers energy output up to 500 mJ. Used by dentists and oral surgeons in clinical settings for soft tissue procedures including incision, excision, ablation, and vaporization. Device enables precise removal of diseased or inflamed tissue, such as periodontal pockets, fibromas, and hyperplasias. Clinician operates laser to target specific oral tissues; laser energy facilitates tissue removal/vaporization. Benefits include controlled surgical intervention for various oral pathologies and preprosthetic preparations. Prescription-only device.
Clinical Evidence
No clinical data provided. Substantial equivalence established via literature review and comparison of specifications to predicate devices.
Technological Characteristics
Erbium:YAG laser; 2.94 micron wavelength; energy output up to 500 mJ. Class II surgical laser. No specific materials or software algorithms described.
Indications for Use
Indicated for patients requiring soft tissue oral and maxillofacial surgery or dental procedures, including incision, excision, ablation, and vaporization of soft tissue, treatment of aphthae, abscess drainage, frenectomy, fibroma excision, gingivectomy, preprosthetic surgery, and periodontal sulcular debridement.
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
SEO TriLase
Laserscope Er:YAG
Premier Centaur
Submission Summary (Full Text)
{0}------------------------------------------------
## K983100
TAB E
## 510(k) SUMMARY
## KaVo KEY Laser 1242
This 510(k) summary of safety and effectiveness for the KaVo KEY Laser 1242 is submitted in accordance with the requirements of SMDA 1990 and follows guidance from the Office of Device Evaluation concerning the organization and content of a 510(k) summary.
| Applicant: | KaVo America Corporation |
|----------------------------------------|-------------------------------------------------|
| | 340 East Main Street |
| | Lake Zurich, IL 60047 |
| Address (Manufacturer): | KaVo Dental GmbH |
| | Bahnhofstr. 20 |
| | D-8847 Warthausen |
| | Biberach |
| | GERMANY |
| Contact Person: | Mr. Douglas Cochrane |
| | Product Manager, KaVo K•E•Y Laser 1242 |
| | KaVo America Corporation |
| | 340 East Main Street |
| | Lake Zurich, IL 60047 |
| Telephone: | 800-323-8029 |
| | 847-550-6800 |
| | 847-550-6825 (Fax) |
| Preparation Date: | July 1998 |
| Device Trade Name: | KaVo K•E•Y Laser 1242 |
| Common Name: | Erbium:YAG surgical laser |
| Classification Name: | Surgical Laser |
| Class: | Class II |
| Legally marketed<br>predicate devices: | SEO TriLase; Laserscope Er:YAG, Premier Centaur |
:
{1}------------------------------------------------
Description of Device: The KaVo KEY Laser 1242 is an Er: Y AG laser operating at 2.94 microns with energy output up to 500 mJ. Intended Use: The KaVo KiE Y Laser 1242 is intended for the incision, excision, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry . . -- • Performance Data: The specifications and intended uses of the KaVo KEY Laser 1242 are the same or very similar to those of the claimed predicate devices. There are no significant differences between the KaVo KEY Laser 1242 and the claimed predicates in design or under conditions of intended use. The notification included an extensive bibliography and discussions of specific articles in support of the claim for equivalence. Because of this, performance data were not required. CONCLUSION: Based on the foregoing, KaVo America Corporation believes that the KaVo
K E Y Laser 1242 is substantially equivalent to cited legally marketed predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent coiled around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 1999
Mr. Doug Cochrane Product Manager KaVo America Corporation 340 East Main Street Lake Zurich, Illinois 60047
Re: K983100 Trade Name: KaVo KEY Laser 1242 Regulatory Class: II Product Code: GEX Dated: December 3, 1998 Received: December 7, 1998
Dear Mr. Cochrane:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2 - Mr. Doug Cochrane
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
TAB DI
510(k) Number (if known): K983100
Device Name KaVo K·E·Y Laser 1242
Indications For Use:
The KaVo KEY Laser 1242 is intended for the incision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following:
Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) Incision for drainage of abscesses Frenectorny, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectomy in the case of hyperplasias of the gingiva or excision of hyperplasias Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papillomas, fibromatoses, benign growths Removal of diseased or inflamed tissue in the periodontal pocket (sulcular debridement)
KaVo proposes that the KaVo KE Y Laser 1242 be labeled as a prescription device. This labeling will be included in manuals and other information distributed in the United States.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter-Use (Per 21 CFR 801.109)
Division of General Re
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
