The modified Coherent VersaPulse Aesthetic Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation, or coagulation) of soft tissue in medical specialties including: dermatology; plastic surgery; and general surgery as follows: a. Laser Wavelengths 532 nm: Non-Q-switched pulsed and Q-Switched modes - Indicated for the removal of light colored tattops (yellow, green, red), treatment of cutaneous lesions including colored vascular lies., port wirini hemangiomas/ stains - PWS), pigmented les lesions - these indications include: The treatment (hemostasis, color lightening, blanching, flattening and reduction of lesion size) of the following general categories of lesions: Vascular lesions - angiomas - hemangiomas (port wine h., cavernous h., cherry h., spider h.) - telangièctasia Benign pigmented lesions - nevi - lentigines (senile and solar) - chloasma - cafe-au-lait (macules) - tattoos - Other pigmented cutaneous lesions - verrucae - skin tags - keratoses - plaques; - 1064 nm: Indicated for the removal of dark colored tatoos (blue-black tatoos), the treatment of cutaneous lesions, including colored vascular lesions (port wine hemangiomas / stains - PWS), and the treatment of pigmented lesions; 755 nm: Indicated for the treatment of pigmented lesions (e.g., epidermal and dermal lesions, including Nevus of Ota/Ito) and of multicolored tattoos, such as black, blue, green and other colors; 2940 nm: Indicated for use in surgical applications requiring excision, incision, ablation, vaporization and coagulation of soft tissue using laser energy emitted by Er: Y AG in general and plastic surgery and dermatology. b. Epidermal Chiller Tip Accessory (Only for Use with 532 nm Wavelength) The Epidermal Chiller Tip accessory, is intended for use only with the 532 nm wavelength, for use in cooling or chilling the epidermis of the treatment site both prior to and during laser treatment to minimize thermal injury to nonvascular structures during laser treatment of telangiectases and other vascular lesions (i.e., port wine stains), to protect the epidermis from thermal necrosis (thus reducing possible complications such as scabbing, scarring, and/or hyperpigmentation), and to minimize the discomfort or degree of pain experienced by the patient during laser treatment due to partial anesthesia from cooling, in dermatology and plastic surgery.
Device Story
Modified Coherent VersaPulse Aesthetic Surgical Laser system delivers multiple laser wavelengths (532 nm, 1064 nm, 755 nm, 2940 nm) for soft tissue surgery. System components include laser console/tower, articulated arm, fiber delivery systems, control/display panels, footswitch/handswitch, and accessories like scanners and epidermal cooling devices. Operated by clinicians in dermatology, plastic surgery, and general surgery settings. Device uses laser energy to perform photothermolysis, excision, incision, ablation, vaporization, and coagulation. Epidermal Chiller Tip accessory provides cooling during 532 nm treatment to protect epidermis and reduce patient discomfort. Clinicians use system controls to adjust energy, repetition rate, and spot size based on lesion type. Output is laser energy delivered to target tissue to achieve hemostasis, lesion removal, or tissue modification, benefiting patients through precise surgical outcomes and reduced thermal injury.
Clinical Evidence
No clinical data submitted. Substantial equivalence determination based on comparison of technical characteristics.
Indicated for patients requiring soft tissue photothermolysis, excision, incision, ablation, vaporization, or coagulation. Specific applications include removal of tattoos (various colors), vascular lesions (angiomas, hemangiomas, telangiectasia), and pigmented lesions (nevi, lentigines, chloasma, cafe-au-lait, verrucae, skin tags, keratoses, plaques). Used in dermatology, plastic surgery, and general surgery.
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
Coherent VersaPulse Aesthetic Surgical Lasers and Delivery Accessories (K960032)
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K972347
### Attachment 12 510(k) Summary Statement for the SEP 1 9 1997 Coherent VersaPulse Aesthetic Surgical Lasers
#### I. General Information
Coherent Medical Group Submitter: 3270 West Bayshore Road Palo Alto, CA 94303
Contact Person: Anne C. Worden
Summary Preparation Date: June 20, 1997
#### II. Names
Device Names: Modified Coherent VersaPulse Aesthetic Surgical Lasers and Delivery Accessories.
Primary Classification Name: Laser Powered Surgical Instrument (and Accessories).
#### III. Predicate Devices
- · Coherent VersaPulse Aesthetic Surgical Lasers and Delivery Accessories (K960032)
- · Candela ALEXLAZR (TL-1) Alexandrite Laser (K944090)
- · Continuum Biomedical Medlite/Erbium 2.94 Surgical Laser (K961748)
#### IV. Product Description
The Coherent VersaPulse Aesthetic Surgical Lasers (and its delivery accessories) are intended to be used to deliver: frequency doubled, Q-switched frequency doubled, and Q-switched Nd:YAG; Q-switched Alexandrite:YAG laser energy for use in surgical applications requiring the photothermolysis (photocoagulation) of soft tissue; and Er:YAG laser energy for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.
Coherent VersaPulse Aesthetic Surgical Lasers are comprised of the following main components:
- · a laser console and tower;
- · a counterbalanced articulated arm and delivery systems;
- · a fiber port and delivery systems;
- · control and display panels;
- · footswitch and handswitch delivery controls;
- · a remote control unit; and
- · a variety of delivery device accessories (articulated arm and fiber handpieces, scanners, and epidermal cooling devices).
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#### V. Indications for Use
The Coherent VersaPulse Aesthetic Surgical Lasers and the Delivery Accessories that are used with them to deliver 532 nm, 1064 nm and 755 nm laser energy that are indicated for use in surgical applications requiring photothermolysis of soft tissue, and 2940 nm laser energy that is indicted for use in surgical applications requiring excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.
#### VI. Rationale for Substantial Equivalence
The Coherent VersaPulse Aesthetic Surgical Lasers and their delivery device accessories share the same indications for use, similar design features (including control system, wavelengths, beam quality, laser tube configuration, active medium, cooling system, and controls and displays), functional features (including power, repetition rate, energy, spot sizes and treatment areas), and therefore are substantially equivalent to the Coherent VersaPulse Aesthetic Surgical Lasers and their delivery device accessories (K960032), the Candela ALEXLAZR (TL-1) Alexandrite Surgical Lasers (K944090), and the Continuum Biomedical Medlite/Erbium 2.94 Surgical Laser (K961748).
#### Safety and Effectiveness Information VII.
No performance data was submitted in conjunction with this Premarket Notification submission. The determination of substantial equivalence was based upon the comparison of the technical characteristics between the modified Coherent VersaPulse Aesthetic Surgical Lasers and the predicate laser systems and accessories.
# VIII. Conclusion
The modified Coherent VersaPulse Aesthetic Surgical Lasers were found to be substantially equivalent to similar currently marketed surgical laser devices. The modified Coherent VersaPulse Aesthetic Surgical Lasers share the same indications for use, similar design features, and similar functional features as the currently marketed surgical lasers and delivery devices.
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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 1997
Ms. Anne C. Worden Senior Manager, Regulatory Affairs Coherent® Medical Group 3270 West Bayshore Road, PO Box 10122 Palo Alto, California 94303-0810
K972347 Re:
> Trade Name: Modified Coherent VersaPulse Aesthetic Surgical Laser Systems and Compatible Delivery System Accessories Regulatory Class: II Product Code: GEX Dated: June 20, 1997 Received: June 24, 1997
Dear Ms. Worden:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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 - Ms. Anne C. Worden
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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,
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Attachment 2 Indications For Use Statement as Requested by FDA
510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________
Device Name : __ Modified Coherent VersaPulse Aesthetic Surgical Laser Systems and
### Compatible Delivery System Accessories
Indications For Use:
The modified Coherent VersaPulse Aesthetic Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation, or coagulation) of soft tissue in medical specialties including: dermatology; plastic surgery; and general surgery as follows:
- a. Laser Wavelengths
- 532 nm: Non-Q-switched pulsed and Q-Switched modes - Indicated for the removal of light colored tattops (yellow, green, red), treatment of
cutaneous lesions including colored vascular lies., port wirini
hemangiomas/ stains - PWS), pigmented les lesions - these indications include:
The treatment (hemostasis, color lightening, blanching, flattening and reduction of lesion size) of the following general categories of lesions:
- Vascular lesions
- angiomas
- hemangiomas (port wine h., cavernous h., cherry h., spider h.)
- telangièctasia
*** Indications For Use Continued on Next Page ***
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K972747
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Attachment 2 - Page 1 Page Amended September 12, 1997
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# Attachment 2 - Continued Indications For Use Statement as Requested by FDA
510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________
Device Name : ___ Modified Coherent VersaPulse Aesthetic Surgical Laser Systems and
## Compatible Delivery System Accessories
Indications For Use:
- Laser Wavelengths Continued from previous page a.
532 nm - Continued:
- Benign pigmented lesions .
- nevi -
- lentigines (senile and solar)
- chloasma -
- cafe-au-lait (macules) -
- tattoos -
- Other pigmented cutaneous lesions .
- verrucae
- skin tags
- keratoses -
- plaques; -
- 1064 nm: Indicated for the removal of dark colored tatoos (blue-black tatoos), the treatment of cutaneous lesions, including colored vascular lesions (port wine hemangiomas / stains - PWS), and the treatment of pigmented lesions;
- 755 nm: Indicated for the treatment of pigmented lesions (e.g., epidermal and dermal lesions, including Nevus of Ota/Ito) and of multicolored tattoos, such as black, blue, green and other colors;
- 2940 nm: Indicated for use in surgical applications requiring excision, incision, ablation, vaporization and coagulation of soft tissue using laser energy emitted by Er: Y AG in general and plastic surgery and dermatology.
- b. Epidermal Chiller Tip Accessory (Only for Use with 532 nm Wavelength)
The Epidermal Chiller Tip accessory, is intended for use only with the 532 nm wavelength, for use in cooling or chilling the epidermis of the treatment site both prior to and during laser treatment to minimize thermal injury to nonvascular structures during laser treatment of telangiectases and other vascular lesions (i.e., port wine stains), to protect the epidermis from thermal necrosis (thus reducing possible complications such as scabbing, scarring, and/or hyperpigmentation), and to minimize the discomfort or degree of pain experienced by the patient during laser treatment due to partial anesthesia from cooling, in dermatology and plastic surgery.
Prescription Use (Per 21 CFR 801.109)
in dermatology and plastic surgery.
---
(Division Sign-Off)
Division of General Res 510(k) Modified Coherent VersaPulse Aesthetic Surgical Argical Servic
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.
