(34 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the hardware components and light delivery mechanism.
Yes.
The device's intended uses, such as hair removal, treatment of vascular and pigmented lesions, and tattoo removal, are all considered therapeutic applications.
No
The "Intended Use / Indications for Use" section lists procedures like hair removal, treatment of vascular and pigmented lesions, and tattoo removal. These are all therapeutic or aesthetic procedures, not diagnostic ones. The device description also focuses on light delivery for these treatments.
No
The device description explicitly details hardware components including a cabinet, power supply, cooling system, microcontroller, umbilical, handpiece, and waveguide.
Based on the provided information, the OmniLight FPL System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (Hair Removal, Permanent Hair reduction, Treatment of Vascular Lesions, Treatment of Pigmented Lesion, Tattoo Removal) are all procedures performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The description details a system that delivers pulsed light to the patient via a handpiece. This is consistent with a therapeutic or aesthetic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, reagents, or diagnostic tests, which are hallmarks of IVDs.
Therefore, the OmniLight FPL System is a device used for therapeutic and aesthetic purposes, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The OmniLight Fluorescent Pulsed Light System is indicated for the following: Hair removal in all skin types Permanent hair reduction Treatment of Vascular Lesions Treatment of Benign pigmented lesions Tattoo removal
The OmniLight FPL System is intended to be used in the following procedures:
- Hair Removal in all Skin types according to the Fitzpatrick Scale
- Permanent Hair reduction
- Treatment of Vascular Lesions
- Treatment of Pigmented Lesion
- Tattoo Removal
Product codes
GEX
Device Description
The OmniLight Fluorescent Pulsed Light System delivers pulsed light at wavelengths starting at 515 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K013365, K022569, K022568, K023081
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
K032191 191
AUG 2 0 2003
510(K) Summary OmniLight Fluorescent Pulsed Light System
This 510(K) Summary of safety and effectiveness for the OmniLight Pulsed Light System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Luxsano AB |
|---|---|
| Address: | Lona Knapes gata 5 |
| 421 32 Vastra Frolunda, | |
| Sweden | |
| Contact Person: | Connie White Hoy |
| Telephone / Fax / Email | 46.31.709.30.70 - Phone |
| 46.31.709.30.79 - Fax | |
| cwhite9901@aol.com | |
| Preparation Date: | May 5, 2003 |
| Device Trade Name: | OmniLight Fluorescent Pulsed Light System |
| Common Name: | Intense Pulsed Light |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX, 21 CFR 878-48 | |
| Legally Marketed Predicate Device: | ProLite and Plasmalite MPX Pulsed Light System |
| K number(s) 013365, 022569, 022568, 023081 | |
| Description of the OmniLight Fluorescent | |
| Pulsed Light System | The OmniLight Fluorescent Pulsed Light System delivers |
| pulsed light at wavelengths starting at 515 nanometers. The | |
| device consists of three interconnected sections: The cabinet | |
| which houses the power supply, the cooling system and the | |
| microcontroller, the umbilical to the handpiece, and the | |
| handpiece, which houses the waveguide | |
| Intended use of the OmniLight Fluorescent | |
| Pulsed Light System | The OmniLight Fluorescent Pulsed Light System is |
| indicated for the following: |
Hair removal in all skin types
Permanent hair reduction
Treatment of Vascular Lesions
Treatment of Benign pigmented lesions
Tattoo removal |
| Performance Data: | None |
| Conclusion: | The OmniLight Pulsed Light System is substantially
equivalent to other existing pulsed light systems in
commercial distribution in Dermatology and Plastic
Surgery. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2003
Luxsano AB c/o Ms. Connie White Hoy 908 Stetson Street Woodland, California 95776
Re: K032191 Trade/Device Name: OmnoLight FPL System 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 5, 2003 Received: July 29, 2003
Dear Ms. Hoy:
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 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 - Ms. Connie White Hoy
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,
Mark N. Millenson
©Sadie McWitter, Ph.D., M.D.
elia M. Witten, Ph.D., M Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATION FOR USE STATEMENT
510(k) Number: ___ fending_ KO3Q19
Device Name: OmniLight FPL System
Indications for Use:
The OmniLight FPL System is intended to be used in the following procedures:
-
- Hair Removal in all Skin types according to the Fitzpatrick Scale
-
- Permanent Hair reduction
-
- Treatment of Vascular Lesions
-
- Treatment of Pigmented Lesion
-
- Tattoo Removal
Mark N. Mullerson
Division of General, Restorative and Neurological Devices
510(k) Number K032191
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use ------------------------------------