(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.
§ 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.