ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV
K990174 · Fisma, Inc. · GEX · Apr 1, 1999 · General, Plastic Surgery
Device Facts
Record ID
K990174
Device Name
ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV
Applicant
Fisma, Inc.
Product Code
GEX · General, Plastic Surgery
Decision Date
Apr 1, 1999
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Ophthalmology: (Atlas-Elite, Elite Ultra) - Retinal Photocoagulation - Trabeculoplasty - Iridotomy - Diabetic Retinopathy - Peripheral Iridectomy - Posterior and Anterior procedures Ear, Nose, & Throat (ENT): (Atlas-Elite, Elite Ultra) - Stapedectomy - Stapedotomy - Myringotomies - Lysis of Adhesions - Control of Bleeding - Removal of Acoustic Neuromas - Soft Tissue Adhesion in Micro/ Macro Otologic procedures * (Elite Ultra [4.0 Watt] only)* - Epistaxis (HHT) - Partial Turbinate Reduction - Vaporization/Coagulation of Granulation Tissue - Photocoagulation or Vaporization of Soft or Fibrous Tissue Dermatology: (Atlas-Elite, Elite Ultra, Corium 200, & Corium 400) - Pigmented Lesions, inc. solar lentigines - Vascular Lesions, inc. cherry hemangiomas & angiokeratomas - Extremities Telangiectasias, inc. facial & leg telangiectasias - Cutaneous Lesions - Flat Warts - Dermatosis - Papulosa Nigra Dentistry (Corium 200, Corium 400) - Frenectomy - Treatment of Oral Mucous Cysts - Treatment of Benign Vascular Lesions: - Capillary Hemangioma - Hemorrhagic Hereditary Telangiectasia - Capillary/Cavernous Hemangiomas - Lymphongioma - AV Malformation of the Tongue - Hemanqiolymphangiomas - Photocoagulation of Superficial Vessels - Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels - Treatment of Superficial Tonque Lesions - Tissue Management and Hemostasis for Crown and Bridge Impressions - Incision and Drainage for Abscess - Gingivoplasty/Gingivectomy: - Operative Procedures - Crown and Bridge, Gingival Retraction - Crown Lengthening - Hyperplasia (Drug, Irritation, Epulis, ... ) - Hemostasis during Dental Procedures - Operculectorny (Operculotomy) - Excisional Biopsy - Free Gingival Graft (Adjunct): - Hemostasis of Donor Site - Hemostasis of Graft Site - Vestibuloplasty - Soften Gutta Percha - Treatment of Canker Sores, Herpetic Lesions, and Aphthous Ulcers - Laser-assisted bleaching/whitening
Device Story
Elite Family Lasers are surgical laser systems utilizing diode-pumped Nd:YAG technology frequency-doubled to 532 nm (green light). Input consists of electrical power; device transforms this into a collimated 532 nm laser beam for photothermolysis/photocoagulation of soft tissue. System includes aiming beam (620-640 nm red diode), delivery handpieces, slit lamp attachments, and indirect ophthalmoscopes. Operated by physicians (ophthalmologists, ENT surgeons, dermatologists, dentists) in clinical settings. Device features interlock safety systems and constant monitoring of power, pulse rates, and energy delivery. Output is controlled laser energy applied to target tissue; healthcare providers use visual feedback to perform procedures. Benefits include precise tissue vaporization, coagulation, and hemostasis, reducing bleeding and improving surgical outcomes in various specialties.
Clinical Evidence
No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.
Technological Characteristics
Energy source: Diode-pumped Nd:YAG rod, frequency-doubled via KTP crystal to 532 nm. Aiming beam: 620-640 nm red diode. Delivery: Collimated handpieces (200-1200 microns), slit lamps, and indirect ophthalmoscopes. Features: Timing controls for interval/duration, interlock safety systems, and digital displays. Connectivity: Standalone surgical system.
Indications for Use
Indicated for patients requiring soft tissue photocoagulation, vaporization, or hemostasis in ophthalmology, ENT, dermatology, and dentistry. Procedures include retinal photocoagulation, trabeculoplasty, iridotomy, stapedectomy, myringotomies, removal of acoustic neuromas, treatment of pigmented/vascular lesions, frenectomy, gingivoplasty, and various oral soft tissue surgeries.
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
Iris Medical Instruments, Inc., DioLite 532 Laser System
Continuum Biomedical Inc., CB Diode/532 Laser System
Laserscope, Aura KTP 532/Green
Submission Summary (Full Text)
{0}------------------------------------------------
Apr-01-99 12:20P FISMA Inc. Quality Team 801 972 4884
K990174
FISMA INC., 3959 West 1820 South Salt Lake City, Utah 84104 (801) 972-0500 (801) 972-4884 (fax) Tracy S. Best, Regulatory Manager Preparation Date: January 13, 1999
Summary of Safety and Effectiveness for the:
Elite Family of Lasers Trade Name:
Diode Nd:YAG Frequency Doubled, 532 nm Common Name:
Classification Name: Laser Instrument, Surgical Powered - 79GEX
# Legally Marketed Predicate Devices for Substantial Equivalence:
*Iris Medical Instruments, Inc., DioLite 532 Laser System
*Continuum Biomedical Inc .. CB Diode/532 Laser System
*Laserscope, Aura KTP 532/Green.
Rationale for SE: The Elite Family Lasers and Delivery Devices share similar indications for use, and similar design features including; wavelengths, beam integrity, and cooling type. Control systems such as interlock devices, (safety systems) and displays are constantly monitored for user intervention. Functional features such as; delivery power, pulse rates, energy type, and spot sizes are also similar to the aforementioned devices. Also see Attachment "A" Comparison Chart of Equivalence.
# Description of Submitted Device:
The Diode Frequency Doubled Green Nd:YAG Surgical Laser System is an instrument used in the application of Photothermolysis (Photocoagulation) of soft tissue using a 532 nm wavelength. The laser light is produced by diode technology. With a higher level of output power of up to 10.0 Watts on future models, additional indications for use are warranted. Indications for use are supported by a line of collimated handpieces with spot sizes of: 200, 400, 600, 800, and 1200 microns, as well as, Slit Lamps (M-140 & M-150), Slit Lamp Attachments, (M-100 & M-101), Indirect Ophthalmoscopes, and Microfilters (Fixed and Moving).
{1}------------------------------------------------
### Intended Uses of the Elite Family Lasers:
See attachment "B" for a complete listing of indicated uses (applied for).
## Technological Characteristics and Substantial Equivalence:
The Elite Family's primary energy output source is a Diode Pumped Nd: YAG Rod, Frequency Doubled using a KTP crystal to a visible green 532 nm laser light for the delivery to the patient and treatment. This system has various timing features for interval, and duration. The Aiming Beam is a Visible Red Diode @ 620-640 nm wavelength.
The Continuum Biomedical. Inc., CB/Diode/532 Laser System uses infrared (808 nm) semiconductor diode laser light as the primary source of energy and is then converted to a visible wavelength of 532 nm laser light. The CB Diode/532 Laser System delivers the same wavelength, similar power, spot sizes and pulses of equivalent duration to the Elite Family.
The Laserscope, Aura Laser System uses arc lamps as the primary form of energy to optically pump a Nd: YAG Rod, the output of which is wavelength converted to visible green 532 nm laser light for the delivery to the patient and treatment. The Aura Laser System delivers the same wavelength, similar average power, pulses of equivalent duration, and treatment spots of equivalent diameter.
The Iris Medical DioLite 532 is a semiconductor-based laser system which delivers 532 nm laser light. The DioLite uses an infrared (808 nm) semiconductor diode laser light as the primary source of energy which is then converted to visible green 532 nm for delivery to the patient and treatment. The system delivers similar average power, durations and intervals. Although the beginning wavelength is different, the final treatment beam to the patient is the same.
#### Conclusion:
The Elite Family Diode Pumped Green Nd: Y AG Frequency Doubled Surgical Laser Systems are substantially equivalent to other existing surgical laser systems in commercial distribution.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1999
Mr. Tracy S. Best Regulatory Manager FISMA, Inc. 3959 West 1820 South Salt Lake City, Utah 84104
K990174 Re: Trade Name: Elite Family of Lasers Regulatory Class: II Product Code: GEX Dated: January 13, 1999 Received: January 19, 1999
Dear Mr. Best:
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.
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Page 2 - Mr. Tracy S. Best
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.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Device Name: Elite Family Lasers (Detailed Below)
#### Indications For Use:
#### Ophthalmology: (Atlas-Elite, Elite Ultra)
- ·Retinal Photocoagulation
- ·Trabeculoplasty
- ·Iridotomy
- · Diabetic Retinopathy
- •Peripheral Iridectomy
- ·Posterior and Anterior procedures Ear, Nose, & Throat (ENT): (Atlas-Elite, Elite Ultra)
- >Stapedectomy
- · Stapedotomy
- ·Myringotomies
- •Lysis of Adhesions
- ·Control of Bleeding
- ·Removal of Acoustic Neuromas
- >Soft Tissue Adhesion in Micro/
- Macro Otologic procedures
- * (Elite Ultra [4.0 Watt] only)*
- * Epistaxis (HHT)*
- *Partial Turbinate Reduction *
- * Vaporization/Coagulation of Granulation Tissue *
- *Photocoagulation or Vaporization of Soft or Fibrous Tissue *
#### Dermatology: (Atlas-Elite, Elite Ultra, Corium 200, & Corium 400)
- •Pigmented Lesions, inc. solar lentigines
- >Vascular Lesions, inc. cherry hemangiomas & angiokeratomas
- ·Extremities Telangiectasias, inc. facial & leg telangiectasias
- ·Cutaneous Lesions
- .Flat Warts
- ·Dermatosis
- •Papulosa Nigra
## Dentistry
## (Corium 200, Corium 400)
- ·Frenectomy
- · Treatment of Oral Mucous Cysts
- · Treatment of Benign Vascular Lesions:
- ·Capillary Hemangioma
- ·Hemorrhagic Hereditary Telangiectasia
- ·Capillary/Cavernous Hemangiomas
- ·Lymphongioma
- ·AV Malformation of the Tongue
- ·Hemanqiolymphangiomas
- · Photocoagulation of Superficial Vessels
- · Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels
- · Treatment of Superficial Tonque Lesions
- · Tissue Management and Hemostasis for Crown and Bridge Impressions
- ·Incision and Drainage for Abscess
- · Gingivoplasty/Gingivectomy:
- ·Operative Procedures
- ·Crown and Bridge, Gingival Retraction
- ·Crown Lengthening
- · Hyperplasia (Drug, Irritation, Epulis, ... )
- ·Hemostasis during Dental Procedures
- · Operculectorny (Operculotomy)
- ·Excisional Biopsy
- >Free Gingival Graft (Adjunct):
- ·Hemostasis of Donor Site
- >Hemostasis of Graft Site
- ·Vestibuloplasty
- · Soften Gutta Percha
- · Treatment of Canker Sores, Herpetic Lesions, and Aphthous Ulcers
- ·Laser-assisted bleaching/whitening
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divisi in Sian-Off
Division of General Restorative Devices K990174
510(k) Number
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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.
