(93 days)
The BIOSYAG MEDICAL SYSTEM is a modular multi-laser and multi-use device for the cosmetic treatment of face and body. It is used to treat common imperfections and lessions of skin and body, including:
- The removal of unwanted hair and to effect stable long term or permanent hair reduction,
- Laser skin treatment procedures for the treatment of: acne scars, wrinkles
- Incision, excision, ablation, vaporisation of soft tissue,
- The non-ablative treatment of facial wrinkles, such as, but not limited to: periocular wrinkles, perioral wrinkles
- Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions.
- Treatment of capillaries, teleangiectasies and vascular lesions.
- Treatment of vitiligo and psoriasis.
The equipment should only be used under medical supervision.
The BIOSYAG MEDICAL SYSTEM is a modular multi-laser and multi-use device for the cosmetic treatment of face and body. It is used to treat common imperfections and lesions of skin and body. The BIOSYAG MEDICAL SYSTEM includes the following light sources: Nd:YAG 50 J (internal laser source) Nd:YAG Q-switched (handpiece) Er:YAG (handpiece) Pulsed Light source. The handpiece is the part that the user grips to carry out the laser treatment and consists of a main body and a removable end section that defines the size of the work beam. At the resonator lead-in an appropriately dimensioned fibre is connected with a focussing device fitted on the end, used to treat the patient. The system is supplied with a set of adapters to be able to use different work beam dimensions. The cooling section consists of a deionised water/air heat exchanger. The foreseen operating cycle is intermittent, operating at maximum power for 10 minutes, followed by a 5 minute pause. The management of the source and the work parameters is by means of a control panel with a liquid crystal colour screen and touch screen functions.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and study information:
This 510(k) summary for the BIOSYAG MEDICAL SYSTEM (K080374) does not contain any information about acceptance criteria or specific studies undertaken to prove the device's performance. Instead, it relies on a claim of substantial equivalence to predicate devices.
Therefore, many of the requested sections will state "Not Applicable" or that no information is provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
No acceptance criteria or reported device performance metrics were provided in the document. The submission relies solely on substantial equivalence to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No test set or clinical study data is presented. The submission relies on substantial equivalence to predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. No ground truth establishment is described as no clinical studies are presented.
4. Adjudication Method for the Test Set
Not Applicable. No test set or clinical data is presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical Performance Data: None." Therefore, no MRMC comparative effectiveness study was conducted or reported.
6. Standalone Performance Study
No. The document explicitly states: "Clinical Performance Data: None." No standalone (algorithm-only) performance study was conducted or reported.
7. Type of Ground Truth Used
Not Applicable. As no clinical studies or performance data are presented, no ground truth was established or used for such purposes in this submission.
8. Sample Size for the Training Set
Not Applicable. No training set is mentioned or implied, as no AI/Machine Learning algorithm development or performance data is presented.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. No training set is mentioned or implied, and consequently, no method for establishing ground truth for a training set is described.
Summary of Document Contents Regarding Performance:
The provided 510(k) summary for the BIOSYAG MEDICAL SYSTEM (K080374) does not include any performance data, clinical study results, or specific acceptance criteria for the device itself. The basis for substantial equivalence is primarily drawn from the device's specifications, functionality, indications for use, and treatment parameters being "the same or very similar" to legally marketed predicate devices (Bios Yag 50 Med and APL Medical System). The document explicitly states "Non-Clinical Performance Data: None" and "Clinical Performance Data: None." This indicates that the manufacturer did not submit new performance data for this particular 510(k) submission, instead relying on the demonstrated safety and effectiveness of the identified predicate devices.
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510(k) SUMMARY
| Submitter: | Bios Italia s.r.l.Via Guido Rossa, 10/1220090 Vimodrone (MI) - Italy | MAY 15 2008 |
|---|---|---|
| Contact: | Aldo Casalino | |
| Date Summary Prepared: | January 21, 2008 (revised April 17, 2008) | |
| Device Trade Name: | BIOSYAG MEDICAL SYSTEM | |
| Common Name: | Medical Laser System | |
| Classification Name: | Instrument, surgical, powered, laserGEX and FTC21 CFR 878.4810 and 21 CFR 878.4630 | |
| Equivalent Device: | BIOS ITALIA S.R.L.• Bios Yag 50 Med - 510(k) nº: K043521• APL Medical System - 510(k) n°: K072344 | |
| Device Description: | The BIOSYAG MEDICAL SYSTEM is a modular multi-laser and multi-use device for the cosmetic treatment of face and body. It is used to treat common imperfections and lesions of skin and body.The BIOSYAG MEDICAL SYSTEM includes the following light sources:Nd:YAG 50 J (internal laser source)Nd:YAG Q-switched (handpiece)Er:YAG (handpiece)Pulsed Light sourceThe handpiece is the part that the user grips to carry out the laser treatment and consists of a main body and a removable end section that defines the size of the work beam.At the resonator lead-in an appropriately dimensioned fibre is connected with a focussing device fitted on the end, used to treat the patient. |
:
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The system is supplied with a set of adapters to be able to use different work beam dimensions. The cooling section consists of a deionised water/air heat exchanger. The foreseen operating cycle is intermittent, operating at maximum power for 10 minutes, followed by a 5 minute pause. The management of the source and the work parameters is by means of a control panel with a liquid crystal colour screen and touch screen functions. The Intended Uses for the BIOSYAG MEDICAL SYSTEM Intended Use: are the following: 1. The removal of unwanted hair and to effect stable long term or permanent hair reduction, 2. Laser skin treatment procedures for the treatment of: . acne scars wrinkles ● 3. Incision, excision, ablation, vaporization of soft tissue, 4. The non-ablative treatment of facial wrinkles, such as, but not limited to: periocular wrinkles . . perioral wrinkles 5. Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions.
-
- Treatment of capillaries, teleangiectasies and vascular lesions.
-
- Treatment of vitiligo and psoriasis.
The correlation between type of light source, wavelength, and intended use is outlined in the table displayed on the following table.
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| LightSource | Wavelength(nm) | Specific Intended Use |
|---|---|---|
| ND:YAG50J (internalsource) | 1064 | - Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions- The non-ablative treatment of facial wrinkles. |
| ND:YAGQ-SWITCHED(handpiece) | 1064+532 | - Laser skin treatment procedures for the treatment of: acne scars; wrinkles- The removal of unwanted hair and to effect stable long term or permanent hair reduction, |
| ER:YAG(handpiece) | 2940 | - Incision, excision, ablation, vaporization of soft tissue,- The non-ablative treatment of facial wrinkles.- Treatment of capillaries, teleangiectasies and vascular lesions, |
| Pulsed Light | 300-1000 | - Treatment of vitiligo and psoriasis (300-380 nm).- The removal of unwanted hair and to effect stable long term or permanent hair reduction (420-950 nm), |
Correlation between BIOSYAG Light Sources, wavelength and Intended Uses
The product specification, functionality, indication for use, Rationale for Substantial and treatment parameters of the APL MEDICAL SYSTEM Equivalence: are the same or very similar to the legally markcted laser Bios Italia srl – Bios Yag 50 Med and APL Medical System. Both systems have the same indication for use. Both systems 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. The BIOSYAG MEDICAL SYSTEM output characteristics (including pulse duration and fluence) are identical, or very similar, to those of the predicate device. Both lasers utilize class IIIA aiming beams. 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 risks and benefits for the BIOSYAG MEDICAL SYSTEM are comparable to those for the predicate device. Therefore, the introduction of this laser should not raise new questions of Safety and Effectiveness.
Non-Clinical Performance Data: None Clinical Performance Data: None
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Image /page/3/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 stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2008
Bios S.R.L.e, Inc. % Onde Consulting, LLC Alessandro Franchi 4235 E. Broadway Long Beach, California 90803
Re: K080374 Trade/Device Name: BIOSYAG MEDICAL SYSTEM
Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical insgrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 20, 2008 Received: March 24, 2008
Dear Alessandro Franchi:
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 - Alessandro Franchi
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (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 M. Millman
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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INDICATION FOR USE STATEMENT
510(k) Number (if known):
D
Device Name:
BIOSY AG MEDICAL SYSTEM
Sponsor Name: Bios Italia s.r.1.
Indication for Use:
The BIOSYAG MEDICAL SYSTEM is a modular multi-laser and multi-use device for the cosmetic treatment of face and body. It is used to treat common imperfections and lessions of skin and body, including:
-
- The removal of unwanted hair and to effect stable long term or permanent hair reduction,
-
- Laser skin treatment procedures for the treatment of:
- . acne scars
- . wrinkles
-
- Incision, excision, ablation, vaporisation of soft tissue,
-
- The non-ablative treatment of facial wrinkles, such as, but not limited to:
- periocular wrinkles .
- perioral wrinkles .
-
- Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions.
-
- Treatment of capillaries, teleangiectasies and vascular lesions.
-
- Treatment of vitiligo and psoriasis.
The correlation between type of light source, wavelength, and intended use is outlined in the table displayed on the following page.
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)
Neil R. Oehler for mrm
(Division Sign-Off)
Prescription Use ম Over-The-Counter Use Division of General, Restorative, and Neurological Devices
510(k) Number_
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| Light Source | Wavelength (nm) | Specific Intended Use |
|---|---|---|
| ND:YAG 50J (internal source) | 1064 | Removal of tattoos and blemishes of the skin, the treatment ofvarious pigmentation lesions |
| The non-ablative treatment of facial wrinkles. | ||
| ND:YAG Q-SWITCHED (handpiece) | 1064+532 | Laser skin treatment procedures for the treatment of: acne scars;wrinkles |
| The removal of unwanted hair and to effect stable long term orpermanent hair reduction, | ||
| ER:YAG (handpiece) | 2940 | Incision, excision, ablation, vaporisation of soft tissue, |
| The non-ablative treatment of facial wrinkles. | ||
| Treatment of capillaries, teleangiectasies and vascular lesions, | ||
| Pulsed Light | 300-1000 | Treatment of vitiligo and psoriasis (300-380 nm). |
| The removal of unwanted hair and to effect stable long term orpermanent hair reduction (420-950 nm), |
rrelation between BIOSYAG Light Sources, wavelength and Intended Us
(Division Sign-Off)
Division of General, Restorative,
Division of General, Restorative,
and Neurological Devices
510(K) Number
§ 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.