(80 days)
No
The device description focuses on hardware components and pulsed light technology, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for the treatment of various medical conditions, including benign pigmented lesions, cutaneous lesions, benign cutaneous vascular lesions, psoriasis, vitiligo, atopic dermatitis, seborrheic dermatitis, and mild to moderate inflammatory acne vulgaris, all of which fall under the scope of therapeutic applications.
No
The device description and intended use outline therapeutic and cosmetic applications, not diagnostic ones. It is used for treatments like tattoo removal, lesion treatment, and hair reduction.
No
The device description explicitly details hardware components such as an umbilical cable, electrical cables, water lines, and a hand piece housing, indicating it is a physical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical, aesthetic, and cosmetic applications requiring selective photothermolysis. This involves direct interaction with the patient's body for treatment purposes.
- Device Description: The description details a pulsed light delivery system that connects to a console. This is consistent with a therapeutic or aesthetic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on specimens taken from the human body. This device's function is to deliver pulsed light directly to the patient's skin for various therapeutic and cosmetic purposes.
N/A
Intended Use / 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. .
Product codes
GEX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulsed light
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General and plastic surgery and dermatology
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033549, K040081, K020941, K032460
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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.
3240 Bayshore Boulevard
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.
1
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.
2
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.
·
3
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.
4
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
5
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