(42 days)
755mn laser:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
On all skin types (Fitzpatrick 1 - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm laser:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Pulsed light FT handpiece:
Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.
Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table:
| Pulsed light | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions |
|---|---|---|---|---|
| Wavelength range | ||||
| 500-1200nm | - | Skin Types I, II | Skin Types I, II | - |
| 520-1200nm | - | Skin Type III | Skin Type III | Skin Types I, II |
| 550-1200nm | Skin Types I, II | - | - | Skin Type III |
| 600-1200nm | Skin Type III | - | - | - |
| 650-1200nm | Skin Type IV | - | - | Skin Type IV |
The Deka Synchro Repla: Y family of lasers is a platform which can be equipped with two separate solid state laser heads (755nm and 1064nm) and a pulsed light handpiece (FT handpiece).
The two laser heads can only be activated separately and they deliver the laser output through the same single laser delivery system, consisting of a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.
The FT handpiece delivers the pulsed light to the treatment area by means of a sapphire lightguide; it is provided with has an integrated skin cooling system and is equipped with five different emission spectra interchangeable filters.
The system allows to switch from one of the three available sources to the other by pressing a key on touch panel.
Handpiece activation is either by footswitch or fingerswitch.
The modifications to the device are two laser handpieces, allowing for a larger treatment area, 22mm and 24mm, and a change of maximum pulse repetition rate for some intermediate settings for the Nd: YAG laser source.
The device hardware did not require any modification to support the new features. Minor changes to the software have been made in order to manage the new handpieces and the modified intermediate settings for the Nd:YAG laser source.
The intended use of the modified device, as described in the labeling, has not changed as a result of the modifications.
This document is a 510(k) Pre-market Notification for the DEKA Synchro Repla:Y family of Laser Systems. It asserts substantial equivalence to a previously cleared device (K131095) rather than providing detailed acceptance criteria and a study proving the device meets those criteria from scratch. Therefore, many of your requested points cannot be extracted directly from this document.
However, based on the provided text, I can infer some information and highlight what is explicitly stated:
Device: DEKA Synchro Repla:Y family of Laser Systems
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the acceptance criteria are implicitly that the new device's performance is equivalent to the predicate device. The document does not provide a table of acceptance criteria in the traditional sense, but rather a comparison of specifications between the new device and the predicate.
| Characteristic | New Device (K150516) | Predicate Device (K131095) |
|---|---|---|
| Laser Type | Alexandrite, Nd:YAG | Alexandrite, Nd:YAG |
| Wavelength | 755 nm, 1064 nm | 755 nm, 1064 nm |
| Max Fluence | 600 J/cm² | 600 J/cm² |
| Spot Sizes | 2.5 to 24mm (modified) | 2.5 to 20mm |
| Pulse Duration | 0.25 to 300 ms | 0.25 to 300 ms |
| Pulse Rep Rate | up to 10 Hz (modified for some intermediate Nd:YAG settings) | up to 10 Hz |
| Skin Cooling System | Yes, optional | Yes, optional |
| Device Type (Pulsed Flashlamp) | Pulsed Flashlamp | Pulsed Flashlamp |
| Wavelengths (nm) (Pulsed Light) | 500-1200nm, 520-1200nm, 550-1200nm, 600-1200nm, 650-1200nm | 500-1200nm, 520-1200nm, 550-1200nm, 600-1200nm, 650-1200nm |
| Pulse Width (Pulsed Light) | 3 - 124 ms | 3 - 124 ms |
| Fluence (Pulsed Light) | 3 - 25 J/cm² | 3 - 25 J/cm² |
| Repetition Rate (Pulsed Light) | 0.5 Hz max. | 0.5 Hz max. |
| Spot Sizes (Pulsed Light) | 48x13 mm | 48x13 mm |
| Method of Skin Cooling (Pulsed Light) | Integrated - provided via the handpiece lightguide | Integrated - provided via the handpiece lightguide |
| Method of Output (Pulsed Light) | Direct Delivery Handpiece | Direct Delivery Handpiece |
The key modifications are the increased spot sizes for the laser heads (up to 24mm from 20mm) and a change in the maximum pulse repetition rate for some intermediate settings of the Nd:YAG laser source. The document states that the intended use and performance are "essentially the same" as the predicate.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data: None" in the Conclusion section. This 510(k) relies on substantial equivalence with minor modifications, not on new performance studies with a test set.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical or non-clinical performance data from a test set are presented.
4. Adjudication method for the test set:
- Not applicable, as no test set data requiring adjudication is presented.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a laser system and does not involve AI or human readers in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as no performance data requiring a ground truth is presented.
8. The sample size for the training set:
- Not applicable, as no machine learning algorithm requiring a training set is involved.
9. How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2015
El. En. Electronic Engineering S.p.A. Mr. Paolo Peruzzi Regulatory Affairs Manager 17 Via Baldanzese Calenzano 50041 Italy
Re: K150516 Trade/Device Name: DEKA SYNCHRO REPLA:Y family of Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: March 13, 2015 Received: March 18, 2015
Dear Mr. Paolo Peruzzi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
{1}------------------------------------------------
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education 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,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Deka Synchro Repla: Y family of laser systems
Indications for Use (Describe)
755mn laser:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
On all skin types (Fitzpatrick 1 - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm laser:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
{3}------------------------------------------------
Pulsed light FT handpiece:
Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.
Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table:
| Pulsed light | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions |
|---|---|---|---|---|
| Wavelength range | ||||
| 500-1200nm | - | Skin Types I, II | Skin Types I, II | - |
| 520-1200nm | - | Skin Type III | Skin Type III | Skin Types I, II |
| 550-1200nm | Skin Types I, II | - | - | Skin Type III |
| 600-1200nm | Skin Type III | - | - | - |
| 650-1200nm | Skin Type IV | - | - | Skin Type IV |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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{4}------------------------------------------------
510(K) Summary
K150516 Deka Synchro Repla: Y family of Laser Systems - Special 510(k)
Submitter:
El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy
Contact:
Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it
Date Summary Prepared:
April 9, 2015
Device Trade Name: Deka Synchro Repla: Y family of Laser Systems
Common Name: Medical Laser and pulsed Light system
Classification Name:
Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology (GEX)
Classification Number:
21 CFR 878.4810
Equivalent Devices:
DEKA Synchro Repla: Y family of laser systems (K131095).
Device Description:
The Deka Synchro Repla: Y family of lasers is a platform which can be equipped with two separate solid state laser heads (755nm and 1064nm) and a pulsed light handpiece (FT handpiece).
The two laser heads can only be activated separately and they deliver the laser output through the same single laser delivery system, consisting of a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.
The FT handpiece delivers the pulsed light to the treatment area by means of a sapphire lightguide; it is provided with has an integrated skin cooling system and is equipped with five different emission spectra interchangeable filters.
The system allows to switch from one of the three available sources to the other by pressing a key on touch panel.
{5}------------------------------------------------
Handpiece activation is either by footswitch or fingerswitch.
The modifications to the device are two laser handpieces, allowing for a larger treatment area, 22mm and 24mm, and a change of maximum pulse repetition rate for some intermediate settings for the Nd: YAG laser source.
The device hardware did not require any modification to support the new features. Minor changes to the software have been made in order to manage the new handpieces and the modified intermediate settings for the Nd:YAG laser source.
The intended use of the modified device, as described in the labeling, has not changed as a result of the modifications.
Intended Use:
755mn laser:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6,9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm laser:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Pulsed light FT handpiece:
Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.
Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table:
| Pulsed lightWavelength range | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions |
|---|---|---|---|---|
| 500-1200nm | - | Skin Types I, II | Skin Types I, II | - |
| 520-1200nm | - | Skin Type III | Skin Type III | Skin Types I, II |
| 550-1200nm | Skin Types I, II | - | - | Skin Type III |
| 600-1200nm | Skin Type III | - | - | - |
| 650-1200nm | Skin Type IV | - | - | Skin Type IV |
{6}------------------------------------------------
Substantial equivalence discussion:
The DEKA Synchro Repla: Y family of laser systems is substantially equivalent to the DEKA Synchro Repla: Y family of laser systems (K131095).
| Device TradeName | DEKA SynchroRepla:Y family oflaser systems | Predicate DeviceK131095DEKA SynchroRepla:Y family oflaser systems |
|---|---|---|
| Laser Type | Alexandrite, Nd:YAG | Alexandrite, Nd:YAG |
| Wavelength | 755 nm, 1064 nm | 755 nm, 1064 nm |
| Max Fluence | 600 J/cm² | 600 J/cm² |
| Spot Sizes | 2.5 to 24mm | 2.5 to 20mm |
| Pulse Duration | 0.25 to 300 ms | 0.25 to 300 ms |
| Pulse Rep Rate | up to 10 Hz | up to 10 Hz |
| Skin CoolingSystem | Yes, optional | Yes, optional |
| Device TradeName | DEKA SynchroRepla:Y family oflaser systems | Predicate DeviceK131095DEKA SynchroRepla:Y family oflaser systems |
|---|---|---|
| Device Type | Pulsed Flashlamp | Pulsed Flashlamp |
| Wavelengths(nm) | 500 - 1200nm520 - 1200nm550 - 1200nm600 - 1200nm650 - 1200nm | 500 - 1200nm520 - 1200nm550 - 1200nm600 - 1200nm650 - 1200nm |
| Pulse Width | 3 - 124 ms | 3 - 124 ms |
| Fluence | 3 - 25 J/cm² | 3 - 25 J/cm² |
| Repetition Rate | 0.5 Hz max. | 0.5 Hz max. |
| Spot Sizes | 48x13 mm | 48x13 mm |
| Method of SkinCooling | Integrated - providedvia the handpiecelightguide | Integrated - providedvia the handpiecelightguide |
| Method ofOutput | Direct DeliveryHandpiece | Direct DeliveryHandpiece |
{7}------------------------------------------------
The DEKA Synchro Repla: Y family of laser systems has the same indications for use as the abovementioned predicate device, with same principle of operation and essentially the same performances.
Clinical Performance Data:
None
Non-Clinical Performance Data:
None
Conclusion:
The Deka Synchro Repla: Y family of laser systems is a family of safe and effective devices for the applications mentioned above.
Additional Information:
None
§ 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.