(245 days)
Not Found
No
The description focuses on the physical characteristics, laser/light types, wavelengths, and intended uses of the device, with no mention of AI or ML capabilities.
Yes
The device is described as a laser and pulsed light system performing procedures such as removal of hair, photocoagulation and hemostasis of various lesions, skin resurfacing, and removal of tattoos, all of which aim to treat existing conditions or alter body functions, aligning with the definition of a therapeutic device.
No
Explanation: The provided text describes the device's functions as various forms of treatment (e.g., hair removal, skin resurfacing, treatment of lesions), not as a tool for identifying or characterizing health conditions. While it treats conditions, it does not diagnose them.
No
The device description clearly outlines a physical laser and pulsed light system with specific hardware components (lasers, handpieces, footswitch/finger switch, power requirements, size, and weight). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a laser and pulsed light system used for various dermatological and cosmetic treatments applied directly to the patient's body (hair removal, lesion treatment, skin resurfacing, tattoo removal, acne treatment).
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient.
The device's intended use and description align with a therapeutic or aesthetic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synchro HP Platform laser and pulsed light system is indicated for the following treatments:
Nd: YAG Laser (1064 nm): removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions.
Er:YAG Laser attachment (2940 nm): skin resurfacing and incision, excision, ablation or vaporization of soft bodily tissues.
Q-switched Nd:YAG Laser attachment (1064 nm): removal of dark tattoos and treatment of benign pigmented lesions.
Pulsed Light attachments (400, 500, 520, 550, 650 to 950 nm): permanent hair reduction, treatment of benign cutaneous vascular lesions including facial and leg veins, benign pigmented epidermal lesions, moderate inflammatory acne vulgaris.
Different wavelength ranges of Pulsed Light attachments are indicated for the various treatments and skin types, as indicated in the following table:
| Pulsed Light wavelength range | Moderate Inflammatory Acne Vulgaris | Benign Cutaneous Vascular Lesions | Benign Pigmented Epidermal Lesions | Permanent Hair Reduction |
|---|---|---|---|---|
| 400 - 950 nm | Skin Types I, II, III, IV | --- | --- | --- |
| 500 - 950 nm | --- | Skin Types I, II | --- | --- |
| 520 – 950 nm | --- | Skin Type III | Skin Types I, II | Skin Types I, II |
| 550 - 950 nm | --- | --- | Skin Types III, IV | Skin Types I, II, III |
| 650 - 950 nm | --- | --- | --- | Skin Type IV |
Product codes
GEX
Device Description
The Synchro HP Platform laser and pulsed light system is equipped with a long pulse Nd: YAG laser (1064 nm), several hand held pulsed light sources (400-950 nm), a hand-held Er: Y AG laser source (2940 nm) and a hand-held Q-switched Nd: Y AG laser source (1064 nm). Emission activation is either by footswitch or finger switch. Overall weight of the system is 170 kg. Size is 115x53x106 cm (HxWxD). Electrical requirement is: 230VAC, 32A, 50-60 Hz, single phase.
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)
Nonclinical 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
1 of 2
510(K) Summary
MAR 2 0 2009 El.En. S.p.A. Submitter: via Baldanzese, 17 50041 Calenzano (FI), Italy Phone: +39-055-882-6807 Fax: +39-055-883-2884 Email: info@elengroup.com Contact: Andrea Tozzi Quality System Manager & Official Correspondent via Baldanzese, 17 50041 Calenzano (FI), Italy Phone: +39-055-882-6807 Fax: +39-055-883-2884 Email: a.tozzi@elen.it Date Summary Prepared: March 19th, 2009 Device Trade Name: Synchro HP Platform Common Name: Medical Laser and Pulsed Light System Classification Name: Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810 K033172 - Candela Gentle YAG Family of Lasers Equivalent Devices: K051442 - Cynosure Photosilk Plus Pulsed Light & Laser Attachments K072564 - Alma Lasers Harmony XL Multi-Application Platform The Synchro HP Platform laser and pulsed light system is equipped Device Description: with a long pulse Nd: YAG laser (1064 nm), several hand held pulsed light sources (400-950 nm), a hand-held Er: Y AG laser source (2940 nm) and a hand-held Q-switched Nd: Y AG laser source (1064 nm). Emission activation is either by footswitch or finger switch. Overall weight of the system is 170 kg. Size is 115x53x106 cm (HxWxD). Electrical requirement is: 230VAC, 32A, 50-60 Hz, single phase. Indications for Use: The Synchro HP Platform laser and pulsed light system is indicated for the following treatments: Nd: YAG Laser (1064 nm): removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions. Er:YAG Laser attachment (2940 nm): skin resurfacing and incision, excision, ablation or vaporization of soft bodily tissues.
1
| K082039 | p. | 2 of 2 | ||
|---|---|---|---|---|
| Indications for Use (continued): | Q-switched Nd:YAG Laser attachment (1064 nm): removal of dark tattoos and treatment of benign pigmented lesions. | |||
| Pulsed Light attachments (400, 500, 520, 550, 650 to 950 nm): permanent hair reduction, treatment of benign cutaneous vascular lesions including facial and leg veins, benign pigmented epidermal lesions, moderate inflammatory acne vulgaris. | ||||
| 400-950 nm Pulsed Light attachment: | ||||
| ✓ Moderate Inflammatory Acne Vulgaris (skin types I, II, III, IV) | ||||
| 500-950 nm Pulsed Light attachment: | ||||
| ✓ Benign Cutaneous Vascular Lesions (skin types I, II) | ||||
| 520-950 nm Pulsed Light attachment: | ||||
| ✓ Benign Cutaneous Vascular Lesions (skin type III) | ||||
| ✓ Benign Pigmented Epidermal Lesions (skin types I, II) | ||||
| ✓ Permanent Hair Reduction (skin types I, II) | ||||
| 550-950 nm Pulsed Light attachment: | ||||
| ✓ Benign Pigmented Epidermal Lesions (skin types III, IV) | ||||
| ✓ Permanent Hair Reduction (skin types I, II, III) | ||||
| 650-950 nm Pulsed Light attachment: | ||||
| ✓ Permanent Hair Reduction (skin type IV) | ||||
| Comparison: | The Synchro HP Platform system has the same indications for use, the same principle of operation, mechanism of action, and very similar performance specifications as the predicate devices. | |||
| Nonclinical Performance Data: | None | |||
| Clinical Performance Data: | None | |||
| Conclusion: | The Synchro HP Platform system is another safe and effective device for the indications specified. | |||
| Additional Information: | None |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2009
El.En. Electronic Engineering SPA % Andrea Tozzi Quality System Manager Via Baldanzese, 17 50041 Calenzano (FI) Italy
Re: K082039
Trade/Device Name: Synchro HP Platform Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in in dermatology Regulatory Class: II Product Code: GEX Dated: March 12, 2009 Received: March 16, 2009
Dear Andrea Tozzi:
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. Iisting 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 (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.
3
Page 2 - Andrea Tozzi
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 yours,
A. U. I. M. for
ark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Statement
c f
510(K) Number (if known): ____K082039
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Nd:YAG Laser (1064 nm): removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular (esions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions.
Er.Y AG Laser attachment (2940 nm): skin resurfacing and incision, excision, ablation or vaporization of soft bodily tissues.
Q-switched Nd: Y A G Laser attachment (1064 nm): removal of dark tattoos and treatment of benign pigmented lesions.
Pulsed Light attachments (400, 500, 520, 550, 650 to 950 mm): permanent hair reduction, treatment of benign cutaneous vascular lesions including facial and leg veins, benign pigmented epidermal lesions, moderate inflammatory acne vulgaris.
Different wavelength ranges of Pulsed Light attachments are indicated for the various treatments and skin types, as indicated in the following table:
| Pulsed Light
wavelength range | Moderate
Inflammatory Acne
Vulgaris | Benign Cutaneous
Vascular Lesions | Benign Pigmented
Epidermal Lesions | Permanent Hair
Reduction |
|----------------------------------|-------------------------------------------|--------------------------------------|---------------------------------------|-----------------------------|
| 400 - 950 nm | Skin Types I, II, III, IV | --- | --- | --- |
| 500 - 950 nm | --- | Skin Types I, II | --- | --- |
| 520 – 950 nm | --- | Skin Type III | Skin Types I, II | Skin Types I, II |
| 550 - 950 nm | --- | --- | Skin Types III, IV | Skin Types I, II, III |
| 650 - 950 nm | --- | --- | --- | Skin Type IV |
Prescriptive Use (Part 21 CFR 801 Subpart D) Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
oncurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Dode Form xm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082039