(282 days)
Not Found
No
The device description focuses on hardware components and a microcontroller for control, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for the treatment of benign cutaneous, vascular, and pigmentary lesions, which are medical conditions, thus qualifying it as a therapeutic device.
No
Explanation: The device is intended for treatment (hair removal, treatment of lesions), not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a central module, handpieces, and a cooling system, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the removal of unwanted hair and the treatment of skin lesions. These are procedures performed directly on the patient's body.
- Device Description: The description details a light-based system with handpieces, a cooling system, and a user interface. This is consistent with a device used for external treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to be used in vitro (outside the body) to examine specimens.
Therefore, STARLIGHT® is a therapeutic device used for external treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
STARLIGHT® is a light-based system intended for the removal of unwanted hair (permanent hair reduction*) and the treatment of benign cutaneous, vascular and pigmentary lesions in skin phototypes I to V of the Fitzpatrick Table.
*Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
Product codes
GEX
Device Description
STARLIGHT® is a light-based system that delivers Intense Pulsed Light in the region of 530 to 1200 nanometers of the Electromagnetic Spectrum. The system has been designed to be compact and self-contained, comprising:
-A central module
-An LCD and soft-touch keyboard interface
-Two application handpieces housing a flash lamp, a light conducting glass w/filter and two shooting buttons
-An integrated Hydraulic Cooling System
The system's electronics and user interface are controlled by a microcontroller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
Not Found
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
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Summary of Performance Studies
Not Found
Key Metrics
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.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '073319'. The handwriting appears to be somewhat stylized, with distinct shapes for each character and number.
SEP - 3 2008 F. P. Rubinstein y Cía. SRL 510(k) Submission STARLIGHT® - Pulsed Light Device
SECTION G - 510(k) SUMMARY
510(k) Summary of Safety and Effectiveness for STARLIGHT®
| Applicant | F. P. Rubinstein y Cía. SRL |
|---|---|
| Address | David Luque 519 - X5004AKM Córdoba, Argentina |
| Contact Person | Haydée N. Demarco (Official Correspondent) |
| Telephone / Fax | +54 351 424 0051 / +54 351 424 7750 |
| Preparation | |
| Date | October 29th, 2007 |
| Device Trade | |
| Name | STARLIGHT® |
| Common Name | Intense Pulsed Light System |
| Classification | |
| Name | Laser surgical instrument for use in General and Plastic |
| Surgery and Dermatology - 21 CFR §878.4810 | |
| Product Code: GEX | |
| Panel: 79 | |
| Class: II | |
| Legally | |
| marketed | |
| Predicate | |
| Device | Skin Station™ System, K030897 |
| System | |
| Description | STARLIGHT® is a light-based system that delivers Intense |
| Pulsed Light in the region of 530 to 1200 nanometers of the | |
| Electromagnetic Spectrum. The system has been designed | |
| to be compact and self-contained, comprising: | |
| -A central module | |
| -An LCD and soft-touch keyboard interface | |
| -Two application handpieces housing a flash lamp, a light | |
| conducting glass w/filter and two shooting buttons | |
| -An integrated Hydraulic Cooling System | |
| The system's electronics and user interface are controlled | |
| by a microcontroller. | |
| Intended Use | STARLIGHT® is a light-based system intended for the |
| removal of unwanted hair (permanent hair reduction*) and | |
| the treatment of benign cutaneous, vascular and | |
| pigmentary lesions in skin phototypes I to V of the | |
| Fitzpatrick Table. | |
| *Permanent hair reduction is defined as a long-term stable reduction in | |
| the number of hairs regrowing after a treatment regime. | |
| Technological | |
| Characteristics | The technological characteristics, performance, intended |
| use, indications, operation and application of STARLIGHT® | |
| are similar to those of the predicate device; therefore no | |
| new questions on safety and effectiveness are raised and a | |
| substantial equivalence is determined. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2008
F.P. Rubinstein y Cía. SRL % Haydée N. Demarco David Luque 519 Cordoba X5004 AKM Argentina
Re: K073317 Trade/Device Name: STARLIGHT® Regulation Number: 21 CFR 878.4810 Regula.ion Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 4. 2008 Received: August 8, 2008
Dear Haydée Demarco:
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 may 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
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Page 2 - Haydée N. Demarco
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Iogal] marketed predicate device results in a classification for your device and thus, perceits 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 Center for Devices and Radiological Health's (CDRH's) Office of Comrobile (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STARLIGHT®
510(k) Number: K073317
Device Name: STARLIGHT®
Indications for Use:
STARLIGHT® is a light-based system intended for the removal of unwanted hair (permanent hair reduction*) and the treatment of benign cutaneous, vascular and pigmentary lesions in skin phototypes I to V of the Fitzpatrick Table.
*Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR (per 21 CFR 801.109)
Over-the-counter Use
(Please do not write below this line – continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olo
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number 10673317