K960086 · Slt-J , Ltd. · GEX · Jun 3, 1996 · General, Plastic Surgery
Device Facts
Record ID
K960086
Device Name
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
Applicant
Slt-J , Ltd.
Product Code
GEX · General, Plastic Surgery
Decision Date
Jun 3, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The DCL8 Enhanced Pulsed Nd:YAG laser system is substantially equivalent to other pulsed Nd:YAG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as, but not limited to: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and laparoscopic procedures.
Device Story
DCL8 Enhanced Pulsed Nd:YAG laser system delivers pulsed laser energy for soft tissue surgery. Input power is 110 VAC. System features red diode aiming beam and touch pad controls for parameter setting. Operated via footswitch or fingerswitch. Uses industry-standard SMA 905 fiberoptic connectors for delivery systems, including NEOS Alloy Scalpels, Fiber Cap, Hybrid Surgical Device, and Fiber Contact Handpieces. Used by clinicians in open, endoscopic, or laparoscopic surgical settings. Laser energy facilitates incision, excision, coagulation, or vaporization of soft tissues. Equivalence established based on shared operating characteristics (power, pulse rates, controls) with predicate Nd:YAG systems.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on technological characteristics, design similarities to predicate devices, and compliance with federal performance standards for medical laser systems.
Technological Characteristics
Pulsed Nd:YAG laser system; 110 VAC power source; SMA 905 fiberoptic connector interface; red diode aiming beam; touch pad control interface; footswitch/fingerswitch operation. Conforms to 21 CFR 1040.10 and 1040.11. Compatible with various cleared fiberoptic delivery systems (e.g., NEOS Alloy Scalpels, Fiber Contact Handpieces).
Indications for Use
Indicated for incision, excision, coagulation, or vaporization of soft tissues, including subcutaneous tissues, striated and smooth muscle, mucous membranes, organs, and glands in open, endoscopic, and laparoscopic procedures.
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
SunLase Master Pulsed Nd:YAG laser system (Sunrise Technologies, Inc.)
SunLase Pulsed Nd:YAG laser system (Sunrise Technologies, Inc.)
PulseMaster 600 Pulsed Nd:YAG laser system (American Dental Technologies)
PulseMaster 1000 Pulsed Nd:YAG laser system (American Dental Technologies)
Reference Devices
Surgical Laser Technologies Nd:YAG laser systems
LCA Nd:YAG laser systems
Laserscope contact fiber handpiece assembly
Submission Summary (Full Text)
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K960086
JUN - 3 1996
# V. SUMMARY OF SAFETY & EFFECTIVENESS
SUMMARY OF 21 CFR 807.87
## A. Device Name:
1. Proprietary Name: DCL8 Enhanced Pulsed Nd:YAG Laser System and Associated Fiberoptic Delivery Systems
2. Common Name: Pulsed Nd:YAG Laser System
## B. Establishment Registration Number:
SLT-J has not yet registered as a medical device establishment with FDA. The company intends to complete all regulatory filings prior to introducing the DCL8 Enhanced Pulsed Nd:YAG laser system into interstate commerce.
Address all correspondence to:
Michael D. Johnson
johnson+associates
5848 Price Road
Milford, OH 45150
513-248-8804
## C. Device Classification:
Pulsed surgical Nd:YAG laser systems are currently considered Class II medical devices subject to pre-market notification provisions for many surgical applications.
Although not formally classified, Nd:YAG surgical laser delivery systems typically have been regulated as Class II devices.
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Electrosurgery handpieces (pencils, electrodes) are considered Class II 79 GEI [21 CFR 878.4400]. SLT-J anticipates these accessory devices would receive the same classification if such delivery systems were officially classified.
## D. Compliance With Standards
The DCL8 Enhanced Pulsed Nd:YAG laser system conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11, for medical laser systems.
Certification reports will be submitted to CDRH certifying compliance with this standard are currently in preparation and will be submitted by SLT-J prior to commercial distribution of this product.
The sponsor is unaware of any specific standards solely for fiberoptic laser delivery systems.
## E. Labeling
Product labels comply with 21 CFR 1040.10 and 1040.11 as applicable. A Operator’s Manual for the DCL8 Enhanced Pulsed Nd:YAG laser system is currently in preparation. A draft Operator’s Manual is included in this submission (see Section II, Device Description).
Product labels comply with 21 CFR 801 as applicable for accessory devices. Copies of the proposed text for these package labels are located in Section IV of this submission.
Promotional materials are not yet in preparation; therefore, they are not included with this submission.
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## F. Equivalence Statement
In the opinion of SLT-J, the Pulsed Nd:YAG laser system is substantially equivalent to the following systems:
- SunLase Master Pulsed Nd:YAG laser system, Sunrise Technologies, Inc., (Fremont, CA)
- SunLase Pulsed Nd:YAG laser system, Sunrise Technologies, Inc. (Fremont, CA)
- PulseMaster 600 Pulsed Nd:YAG laser system, American Dental Technologies (Troy, MI)
- PulseMaster 1000 Pulsed Nd:YAG laser system, American Dental Technologies (Troy, MI)
## G. Summary of Safety and Effectiveness
The DCL8 Enhanced Pulsed Nd:YAG laser system is substantially equivalent to other pulsed Nd:YAG laser systems currently marketed by Sunrise Technologies (Fremont, CA) and American Dental Technologies (Troy, MI)
This belief is based upon the following facts:
1. The DCL8 Enhanced Pulsed Nd:YAG laser system is substantially equivalent to other pulsed Nd:YAG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as, but not limited to: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and laparoscopic procedures. The delivery systems which can be used in conjunction with the DCL8 Enhanced Pulsed Nd:YAG laser system have previously been cleared for marketing by the FDA.
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2. The DCL8 Enhanced Pulsed Nd:YAG laser system has the same operating characteristics as the pulsed Nd:YAG laser systems offered by Sunrise Technologies and American Dental Technologies with respect to average power to tissue, pulse rates, operating controls and indicators. The DCL8 Enhanced Pulsed Nd:YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd:YAG laser systems offered by Sunrise Technologies and American Dental Technologies.
3. The DCL8 Enhanced Pulsed Nd:YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. This is identical to the connector systems used by Sunrise Technologies and American Dental Technologies. The delivery systems which will be used with the DCL8 Enhanced Pulsed Nd:YAG laser system have previously received market clearance for use with Nd:YAG laser systems to which the delivery systems can be attached.
4. The DCL8 Enhanced Pulsed Nd:YAG laser system can be operated by either a footswitch or a fingerswitch. This technology is equivalent to, and has been offered since 1990 on Nd:YAG laser systems offered by Surgical Laser Technologies (The Oaks, PA) and LCA (Cincinnati, OH). This allows the operator to select between either footswitch or fingerswitch control of the delivery system.
5. Many of the delivery systems (NEOS Alloy Scalpels, Fiber Cap, Hybrid Surgical Device, Closed End, Closed End/Electrocautery and Bipolar Dissector) which are to be used with the DCL8 Enhanced Pulsed Nd:YAG laser system have already received market clearance for use with other Nd:YAG laser systems. Because of the configuration of these delivery systems, i.e., delivery of laser light to tissues, the source of laser energy is not important. The delivery systems still interact
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with tissue in a similar manner, regardless of the input (laser) source. The Super Scalpel behaves in a similar manner.
The Fiber Contact Handpiece is equivalent to those offered currently by Sunrise Technologies (Fremont, CA) and American Dental Technologies (Troy, MI) for their pulsed Nd:YAG laser systems. Additionally, Laserscope (San Jose, CA) offers an equivalent contact fiber handpiece assembly.
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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.
