(49 days)
Not Found
No
The device description focuses on the laser technology, optical delivery system, power supply, cooling system, and a microprocessor-based controller. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices.
Yes
The device is intended for the treatment of various medical conditions, including vascular lesions, pigmented lesions, and for hair removal, which are therapeutic applications.
No
Explanation: The device is described as a Q-Switched laser intended for treatment of various conditions (vascular lesions, pigmented lesions, hair removal, soft tissue incision/excision/ablation/vaporization, and tattoo removal), not for diagnosis.
No
The device description explicitly details hardware components such as a laser source, optical delivery system, power supply, cooling system, and microprocessor-based controller.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The description clearly states that this device is a laser intended for treatment of various conditions (vascular lesions, pigmented lesions, hair removal, soft tissue procedures, tattoo removal). It directly interacts with the patient's body to perform these treatments.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens (blood, tissue, etc.) outside of the body.
Therefore, this device falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (blue, black and green tattoo)
Nd: YAG (532nm):
The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The device includes a Q-Switched Nd: YAG laser source with 900mJ max energy at 1064 nm and 450mJ max energy at 532 nm wavelengths. The optical delivery system for the two wavelengths is the articulated arm. In addition, the DUOLITE includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY Quanta System DUOLITE
Laser surgical instrument for use in general surgery and
Cynosure, Inc Affinity QS Q-Switched Nd: YAG Laser
tattoo removal ( blue, black and green tattoo)
wavelengths is the articulated arm.
The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE O-Switched laser is intended for
The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)
The device includes a Q-Switched Nd: YAG laser source with
532 nm wavelengths. The optical delivery system for the two
In addition, the DUOLITE includes a power supply; a cooling system; an optical delivery system; a microprocessor based
900mJ max energy at 1064 nm and 450mJ max energy at
controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.
Submitter:
Contact:
Title:
Quanta System SpA via IV Novembre, 1 16 21058 Solbiate Olona VA / Italy
Dr. Maurizio Bianchi QA and Regulatory Affairs Manager
Instrument, surgical, powered, laser
February 28, 2013
System (K050382);
Nd:YAG (1064nm):
Nd:YAG (532nm):
None
Dermatology
Date Prepared:
Quanta System DUOLITE Device Trade Name:
Common Name:
Classification Name:
Predicate Devices:
Intended Use / Indications for use:
Technological Characteristics:
Performance data:
Substantial Equivalence: The Quanta System DUOLITE is as safe and effective as the predicate devices. The DUOLITE has the same intended uses and similar indications, technological characteristics,
Page 4 of 55
1
| | Wavelength
[nm] | pulse
width
[ns] | Fluence
[J/cm²] | spot
size
[mm] | Rep.
rate
[Hz] |
|--------------------------------------|--------------------|------------------------|---------------------------------------------------------------------|----------------------|----------------------|
| QUANTA
SYSTEM
DUOLITE | 1064 nm | 6 ns | 28J/cm² at 2mm
12J/cm² at 3mm
3J/cm² at 6mm | 2,3 and
6mm | 1,2,5
and
10Hz |
| | 532 nm | 6 ns | 14J/cm² at 2mm
6J/cm² at 3mm
1,5J/cm² at 6mm | 2,3 and
6mm | 1,2,5
and
10Hz |
| CYNOSURE
AFFINITY
QS (K050382) | 1064 nm | 6 ns | 28J/cm² at 2mm
12J/cm² at 3mm
7J/cm² at 4mm
3J/cm² at 6mm | 2,3,4
and
6mm | 1,2,5
and
10Hz |
| | 532 nm | 6 ns | 14J/cm² at 2mm
6J/cm² at 3mm
3J/cm² at 4mm
1,5J/cm² at 6mm | 2,3,4
and
6mm | 1,2,5
and
10Hz |
and principles of operation as its predicate device as demonstrated in the table below.
The tip of the handpiece of the DUOLITE is made of Biocompatible material as the predicate device. This Sterilization method is the same as its predicate device. The Minor technological differences between the DUOLITE and its predicate devices raise no new issue of safety or effectiveness. Thus, the DUOLITE is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Quanta System, S.P.A. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313
March 15, 2013
Re: K103539 Trade/Device Name: DUOLITE 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: January 06, 2011 Received: January 07, 2011
Dear Mr. Job:
This Letter corrects our substantially equivalent letter of January 20, 2011.
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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Mark Job
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
DUOLITE Device Name:
Indications for use:
Nd:YAG (1064nm):
The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (blue, black and green tattoo)
Nd: YAG (532nm):
The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)
Neil R Ogdens 2013.03.15 12:54:24 -04'00'
(Division Sign Off) for MXM Division of Surgical, Orthopedic, And Restorative Devices
510(k) Number K103539 .
Prescription Use AND/OR ਮ (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)