K050047 · Cutera, Inc. · GEX · Mar 31, 2005 · General, Plastic Surgery
Device Facts
Record ID
K050047
Device Name
CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY
Applicant
Cutera, Inc.
Product Code
GEX · General, Plastic Surgery
Decision Date
Mar 31, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Cutera Optional Pulsed Light Hand Piece Family is indicated for use in the surgical, aesthetic and cosmetic applications requiring selective photothermolysis in the medical specialties of general and plastic surgery and dermatology. The Cutera Optional Pulsed Light Hand Piece Family is intended for the treatment of: - Tattoos; - Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); - Cutaneous lesions including warts, scars and striae; - Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, roasacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; - Psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; - Removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and - Mild to moderate inflammatory acne vulgaris.
Device Story
Pulsed light hand pieces accessory to Cutera console systems; utilizes xenon flash lamp for selective photothermolysis. Components include umbilical cable, connector, electrical cables for thermoelectric cooling and lamp power, water lines for heat removal, and memory device for hand piece identification. Operated by physicians in dermatology, plastic, or general surgery settings. Device delivers light energy to target tissues; healthcare provider monitors output via console controls. Clinical benefit includes treatment of vascular/pigmented lesions, hair reduction, and acne management. System uses thermoelectric cooling at the tip to manage thermal effects on skin.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on technological characteristics and indications for use comparable to legally marketed predicate devices.
Technological Characteristics
Pulsed light (flash lamp) delivery system; xenon flash lamp source; thermoelectric cooling; umbilical cable with water cooling and electrical connections; memory device for hand piece identification. Accessory to previously cleared Cutera console systems.
Indications for Use
Indicated for patients requiring selective photothermolysis for tattoos, benign pigmented lesions (dyschromia, hyperpigmentation, melasma, freckles), cutaneous lesions (warts, scars, striae), benign vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, poikiloderma, leg veins), dermatological conditions (psoriasis, vitiligo, dermatitis), hair reduction, and mild to moderate inflammatory acne vulgaris.
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.
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K050047 p. 1 of 3
Premarket Notification 510(k) Submission: Cutera Optional Pulsed Light Hand Piece Family
### Attachment 15 510(k) Summary for the Cutera Optional Pulsed Light Hand Piece Family
#### General Information l.
| Submitter: | Cutera Inc.<br>3240 Bayshore Boulevard<br>Brisbane, CA 94005 |
|-----------------|--------------------------------------------------------------|
| Contact Person: | Kathy Maynor |
Summary Preparation Date: December 29, 2004
#### II. Names
| Device Names: | Cutera Optional Pulsed Light Hand Piece Family |
|------------------------------|----------------------------------------------------|
| Primary Classification Name: | Laser Powered Surgical Instrument (and Accessories |
#### III. Predicate Devices
- Starlux/Estelux pulsed light hand pieces manufactured by Palomar (K033549, . K040081, K020941)
- Profile BBL manufactured by Sciton (K032460) .
- PRIMA Pulsed Light Therapy System manufactured by CoolTouch. .
#### IV. Product Description
The pulsed light delivery hand pieces are comprised of four main components:
- an "umbilica!" cable and connector, that is permanently attached to the hand A piece body and is semi-permanently attached to the console system (detachable by positive action from the user) that houses:
- electrical cables (to support the thermoelectric cooler associated with the A chilled hand piece tip, to provide power and a trigger source to the xenon flash lamp, to provide detector signals and to connect a memory device that identifies the hand piece);
- a supply and return water line (to remove the heat generated by the flash lamp A and thermoelectric cooler);
- the hand piece internals described above; and A
- the hand piece housing the internals and connecting to the umbilical. A
These hand pieces are accessories to be used on previously cleared Cutera console systems where the 510(k) permitted use of pulsed light (a.k.a. flash lamp) hand pieces.
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### Indications for Use V.
The Cutera Optional Pulsed Light Hand Piece Family is indicated for use in the The Cutera Optional I cosmetic applications requiring sclective photothermolysis in the medical specialties of general and plastic surgery and dermatology.
KOSODY
ﮩﺴ
The Cutera Optional Pulsed Light Hand Piece Family is intended for the treatment of:
- Tattoos; .
- including dyschromia, hyperpigmentation, Benign pigmented lesions . melasma, ephelides (freckles);
- Cutaneous lesions including warts, scars and striae; .
- Benign cutaneous vascular lesions, including port wine stains, hemangiomas, . facial, truncal and leg telangiectasias, roasacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- Psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; ●
- Portually, Things, I hair from all skin types, and to effect stable long-term, . or permanent, hair reduction; and
- Mild to moderate inflammatory acne vulgaris. .
#### Rationale for Substantial Equivalence VI.
The Cutera Optional Pulsed Light Hand Piece Family shares the same indications for use, similar design features (including wavelength, light generation medium, power supply, similar control system), functional features (including power output, spot size, cooning and conder by and fluence), and is therefore substantially equivalent to the above legally marketed predicate devices.
#### Safety and Effectiveness Information VII.
The new indications for use are based upon the indications for use for predicate pulsed light device systems.
Technologically, the Cutera Optional Pulsed Light Hand Piece Family is substantially equivalent to the listed predicate devices. Therefore the risks and benefits for the Cutera Optional Pulsed Light Hand Piece Family are comparable to the predicate devices.
We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of this device.
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050047 p 3q3
# VIII. Conclusion
The Cutera Optional Pulsed Light Hand Piece Family was found to be substantially The Cutera Optional Fulscu Light Traile Tredo The Cutera Optional Pulsed Light Hand Picce Family shares similar indications for use, design foatures, and similar Hand Picce Family Shares Sinhial Indications To, acc, The currently marketed predicate devices.
·
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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is represented by three curved lines that resemble a stylized staff with a snake winding around it.
MAR 3 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathy Maynor Vice President of Regulatory/Quality Cutera, Inc. 3240 Bayshore Boulevard Brisbane, California 94005
Re: K050047
Trade/Device Name: Optional Pulsed Light Hand Piece Family 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 Dated: December 31, 2004 Received: January 10, 2005
Dear Ms. Maynor:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure, to regary mannent date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the enaordance with the provisions of the Federal Food. Drug. devices that have been resuire approval of a premarket approval application (PMA). alla Cosmetic Act (11ct) that do novice, subject to the general controls provisions of the Act. The r ou may, mercrore, mans of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device is elassified (soc abor of als. Existing major regulations affecting your device can may be subject to suble additions, Title 21, Parts 800 to 898. In addition. FDA may be found in the exte of reants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast be advised that I be a letermination that your device complies with other requirements of the Act that 1197 has Intact a and regulations administered by other Federal agencies. You must or any i call 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 (21 CFR Part 820); and if applicable, the electronic forth in the quart) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Ms. Kathy Maynor
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms icher witi anow you to begin manies. 3.
premarket notification. The FDA finding of substantial equivalence of your device to a legally prematicate 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 If you desire specific acrise is 9 % (240) 276-0115. Also, please note the regulation entitled. Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological 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): | K0500 |
|---------------------------|-------|
|---------------------------|-------|
# Device Name: Cutera Optional Pulsed Light Hand Piece Family
Indications For Use:
The Cutera Optional Pulsed Light Hand Piece Family is indicated for use in the surgical, aesthetic and cosmetic applications requiring selective photothermolysis in the medical specialties of general and plastic surgery and dermatology.
The Cutera Optional Pulsed Light Hand Piece Family is intended for the treatment of:
- Tattoos: .
- Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, . ephelides (freckles);
- Cutaneous lesions including warts, scars and striae; .
- Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, . truncal and leg telangiectasias, roasacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- Psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; ●
- Removal of unwanted hair from all skin types, and to effect stable long-term, or . permanent, hair reduction; and
- Mild to moderate inflammatory acne vulgaris. .
Prescription Use ー (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
### (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,
and Neurological Devices
510(k) Number C050047
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.
