(99 days)
Not Found
No
The summary describes a device based on selective thermolysis using optical and RF energy. There is no mention of AI, ML, image processing, or any data-driven algorithms for diagnosis, treatment planning, or device operation. The description focuses on the physical principles of the technology.
Yes
The device is indicated for the treatment of various medical conditions, specifically superficial benign vascular lesions like Telangiectasias, Rosacea, Poikiloderma, and Angioma, as well as superficial benign pigmented lesions, which falls under the definition of a therapeutic device.
No
The device is indicated for treatment (hair removal, treatment of vascular lesions) using selective thermolysis, not for diagnosing conditions.
No
The device description explicitly states it is a "device that is used for hair removal... and for treatment of superficial benign vascular lesions," and describes the treatment principle based on "optical and RF energy," indicating it is a hardware-based system that delivers energy.
Based on the provided information, the Pitanga device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Pitanga's Function: The Pitanga device is described as being used for hair removal and the treatment of superficial benign vascular and pigmented lesions. This is a therapeutic or treatment function, not a diagnostic one. It directly interacts with the body to achieve a physical effect (hair removal, lesion treatment) rather than analyzing a sample to diagnose a condition.
- Lack of Diagnostic Language: The description focuses on the mechanism of action (selective thermolysis) and the intended treatment outcomes, not on analyzing biological samples or providing diagnostic information.
Therefore, the Pitanga device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pitanga is intended for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions.
Product codes
GEX
Device Description
The Pitanga is a device that is used for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions. The Pitanga treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage pigmented and vascular lesions without damaging the surrounding tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face, leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
AUG 1 9 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. PITANGA K031489
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter: Syneron Medical Ltd., Sultam Industrial park, P.O.B. 550, Yokneam Elite 20692, Israel. Tel. +972-4-909-7424 ext. 7604, Fax +972-4-909-7417
Name of the Device: Pitanga family of products
- The Pitanga is substantially equivalent to a combination of the Predicate Devices: following devices: the Aurora DS, manufactured by Syneron Medical Ltd. and subject of K021149 ; the Aurora SR, manufactured by Syneron Medical Ltd. and subject of K022266. Lumenis family of intense pulse light (IPL) and IPL/Nd:YAG laser systems manufactured by Lumenis Inc. and subject of K020839.
- Device Description: The Pitanga is a device that is used for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions. The Pitanga treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage pigmented and vascular lesions without damaging the surrounding tissues.
The Pitanga is intended for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions.
Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit. Therefore the Pitanga should raise no new issues of safety or effectiveness.
May 8, 2003
Avis Waldum
Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.
Date
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2003
Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical, Inc. Sultam Industrial Park P.O.B 550 Yokneam Elite 20692. Israel
Re: K031489 Trade/Device Name: Pitanga family of products 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: May 8, 2003 Received: May 21, 2003
Dear Dr. Waldman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Dr. Amir Waldman
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Millican
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name
Indications For Use:
The Pitanga is indicated for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superfícial benign pigmented lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V (Per 21 CFR 801.109)
OR
Over The Counter Use_
(Optional Format 1-2-96)
f. Merle A. Mullener
1, Restorative
510 Number K031489