(94 days)
Not Found
No
The device description details a laser system with a microprocessor-based controller for regulating functions and parameter selection, but there is no mention of AI or ML capabilities in the description, intended use, or performance studies.
Yes
The device is indicated for "treatment of benign vascular lesions and hair reduction," which are therapeutic applications.
No
The device description and intended use indicate it is an Nd:YAG laser for treatment of benign vascular lesions and hair reduction, which are therapeutic applications, not diagnostic.
No
The device description clearly outlines multiple hardware components including a laser, power supply, cooling system, optical delivery system, and handpiece.
Based on the provided information, the BIOSY AG 50 Med laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "treatment of benign vascular lesions and hair reduction." This describes a therapeutic application directly on the patient's body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a laser system that delivers energy to the patient's tissue. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Providing information for diagnosis, monitoring, or screening.
In summary, the BIOSY AG 50 Med laser is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BIOSYAG 50 Med laser is indicated for benign vascular lesions and hair removal.
The BIOSYAG 50 Med laser is indicated for treatment of benign vascular lesions and hair reduction. The equipment should only be used under medical supervision.
Product codes
GEX
Device Description
The BIOSYAG 50 Med laser is a pulse Nd: YAG laser utilizing the Nd:YAG crystal as the lasing medium. It is a pulsed laser with wavelength of 1064 nm.
Within the system an optical cavity contains the Nd: YAG crystal which is activated by means of the use of flash lamps. After the cavity a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beam are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode. The BIOS YAG 50 Med laser is composed by 5 major subsystems:
- a) A high voltage power supply which converts and rectifies the a.c. main current to provide regulate power for the flashlamp simmer current and main triggering pulse.
- b) A cooling system consisting of an internal water flow circuit with water-to-air hath exchanger.
- c) An optical delivery system, interfacing the energy from the laser to patient via an optical fiber and focusing handpiece. d} A microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
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)
Non-Clinical Performance Data: None
Clinical Performance Data: None
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
Bios s.r.l. BIOSYAG 50 Med CONFIDENTIAL
K043521, p. 1 of 2
510(k) Premarket Notification
(5001)
page 5 of 12
510(k) SUMMARY
MAR 2 4 2005
| Submitter: | Bios s.r.l. |
|---|---|
| Via Pisa, 61 | |
| 20093 Cologno Monzese (MI) – Italy |
Contact:
Aldo Casalino
BIOSYAG 50 Med
Medical Laser System
September 30, 2004 Date Summary Prepared:
Device Trade Name:
Common Name:
Classification Name:
Equivalent Device:
Device Description:
Instrument, surgical, powered, laser 79 – GEX 21 CFR 878.4810
Cynosure Smartepil (K020107)
The BIOSYAG 50 Med laser is a pulse Nd: YAG laser utilizing the Nd:YAG crystal as the lasing medium. It is a pulsed laser with wavelength of 1064 nm.
Within the system an optical cavity contains the Nd: YAG crystal which is activated by means of the use of flash lamps. After the cavity a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly.
The combined therapeutic and aiming beam are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode. The BIOS YAG 50 Med laser is composed by 5 major subsystems:
- a) A high voltage power supply which converts and rectifies the a.c. main current to provide regulate power for the flashlamp simmer current and main triggering pulse.
- b) A cooling system consisting of an internal water flow circuit with water-to-air hath exchanger.
1
Bios s.r.l. BIOSYAG 50 Med CONFIDENTIAL
K04 3521, p 2 of 2
510(k) Premarket Notification
page 6 of 12
- c) An optical delivery system, interfacing the energy from the laser to patient via an optical fiber and focusing handpiece. d} A microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user. The BIOS YAG 50 Med laser is indicated for benign Intended Use: vascular lesions and hair removal. Rationale for Substantial The product specification, functionality, indication for use, and treatment parameters of the The BIOSYAG 50 Med Equivalence: laser are the same or very similar to the legally marketed laser Cynosure Smartepil. Both equipments have the same indication for use. Both system comprise a flashlamp pumped laser rod (Nd: YAG) generating light at a wavelength of 1064 nm, which is subsequently delivered to the patient via an optical fiber delivery system and focusing handpiece. BIOSY AG 50 Med output characteristics (including pulse duration and fluence) are identical, or very similar, to those of predicate device. Both lasers utilize class IIIA aiming beam. Both lasers are microprocessor controlled devices. Both systems utilize an internal closed loop water-air heath exchanger circuit for optimal thermal control of laser cavity The risk and benefits for the BIOSYAG 50 Med are comparable to the predicate device, it is therefore believed that there are no new questions of Safety and Effectiveness raised by the introduction of this device.
Non-Clinical Performance Data: None
Clinical Performance Data: None
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an abstract human figure with three wavy lines representing the body and head.
MAR 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bios s.r.l. c/o Mr. Allessandro Franchi Quality Management & Services 16 Indian Spring Drive Silver Spring, Maryland 20901
Re: K043521
Trade/Device Name: BIOSYAG 50 Med 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: March 11, 2005 Received: March 14, 2005
Dear Mr. Franchi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed 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 regars the Medical Device Amendments, or 10 comments prior to May 20, 1976, the encordance with the provisions of the Federal Food. Drug. devices that have been reculsion in acce approval of a premarket approval application (PMA). and Cosmetic Act (7101) that do hot required to the general controls provisions of the Act. The r ou may, therefore, manver the Act include requirements for annual registration, listing of general controls provision gractice, 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 olassimod (600 as courols. Existing major regulations affecting your device can may be subject to satin additions, Title 21, Parts 800 to 898. In addition. FI >> 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 that I Dri has made a associations administered by other Federal agencies. You must or any I edolar studies and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set el 11 Fart 6077, adoming (21 (QS) regulation (21 CFR Part 820); and if applicable. the electronic forth in the quanty byttellio (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Allessandro Franchi
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 prestiation onedicate 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 (240) 276-0115. 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/industry/support/index.html
Sincerely yours,
signature
Miriam C. Provost, Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Bios s.r.l. BIOSYAG 50 Med CONFIDENTIAL
page 4 of 12
INDICATION FOR USE STATEMENT
K043521 /S001
510(k) Number (if known):
Device Name:
BIOSYAG 50 Med
Bios s.r.1. Sponsor Name:
Indication for Use:
The BIOSY AG 50 Med laser is indicated for treatment of benign vascular lesions and hair reduction.
The equipment should only be used under medical supervision.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Over-The-Counter Use
Zhe Man