(175 days)
755 nm: The CLARITY II 755 nm Laser System is indicated for temporary hair reduction and stable long-term or permanent 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. The 755 nm laser is also indicated for treatment of benign pigmented lesions, vascular lesions and wrinkles.
1064 nm: The CLARITY II 1064 nm Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I -VI, including tanned skin. 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. The 1064 nm laser is also indicated for coagulation and hemostasis of soft tissue, for hemostasis of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 nm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The CLARITY II Laser System contains two separate resonators, an Alexandrite resonator and an Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelength 755 nm and 1064 nm, respectively. The outputs of each laser generator and the aiming beam are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 755 nm or 1064 nm wavelength. It is a medical device, designed for specific clinical applications, emitting laser energy via a handpiece and controlled by the user with a handpiece finger switch or optional footswitch. The CLARITY II Laser System consists of a system main body with an LCD touch screen, optical fiber with an AC or ICD handpiece.
The provided text is a 510(k) summary for the CLARITY II Laser System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed performance studies with acceptance criteria, ground truth, or statistical analysis typical for a de novo or PMA submission of an AI-powered diagnostic device.
Therefore, the specific information requested in the prompt about acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training is not present in this document. The device in question is a laser system for dermatological treatments, not an AI diagnostic tool.
However, I can extract the information that is available and clarify what is missing based on your prompt.
Summary of Device Performance and Equivalence
The CLARITY II Laser System is being submitted as substantially equivalent to the CLARITY LPC Laser System (K130199) and the Elite + Laser (K141425). Substantial equivalence means that the device has the same intended use and technological characteristics as the predicate device, or if there are differences, they do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Type of Acceptance Criteria (Not Explicitly Stated as AC, but as basis for SE) | CLARITY II Laser System Performance (Reported as technological characteristics similar to predicates) | Predicate Device 1: CLARITY LPC (K130199) | Predicate Device 2: Elite + (K141425) |
|---|---|---|---|---|
| 755 nm | - Max Fluence (J/cm²) | 600 | 600 | 60 |
| - Max Energy (J) | 60 | 60 | 30 | |
| - Max Rep Rate (Hz) | 10 | 10 | 5 | |
| - Pulse Duration (ms) | 0.1 - 300 | 0.35 - 300 | 0.1 - 300 | |
| - Spot Sizes (mm) | 2,3,5,8,10,12,15,16,18,20,22,24 | 2,3,5,8,10,12,15,18,20 | 3,5,7,10,12,15,18,20,22,24 | |
| 1064 nm | - Max Fluence (J/cm²) | 600 | 600 | 300 |
| - Max Energy (J) | 100 | 100 | 50 | |
| - Max Rep Rate (Hz) | 10 | 10 | 10 | |
| - Pulse Duration (ms) | 0.1 - 300 | 0.35 - 300 | 0.1 - 300 | |
| - Spot Sizes (mm) | 2,3,5,8,10,12,15,16,18,20,22,24 | 2,3,5,8,10,12,15,18,20 | 3,5,7,10,12,15,18,20,22,24 | |
| Common Features | - Aiming Beam | Green | Green | Red |
| - Electrical Requirements | AC220-230V 50/60 Hz; Fuse: 250V/30A, Circuit Breaker: 30A; Power Consumption: 6.0 kVa | VAC 220-230, single phase, 30A, 50/60 Hz | VAC 208/240, single phase, 30A, 50/60 Hz | |
| - Size (mm) | 563.6 (W) x 952.3 (L) x 998.5 (H) mm | 434 (W) x 776.8 (D) x 1148.8 (H) | 381 (W) x 635 (D) x 1041.4 (H) | |
| - Weight (kg) | 110 | 110 | 81.8 | |
| - Optical Delivery System | Optical fiber with handpiece | Optical fiber with handpiece | Optical fiber with handpiece | |
| - Cooling System | Chilled Air or ICD | Chilled Air or ICD | Chilled Air | |
| Distinguishing Features | - Skin temperature monitoring | Included (informational only) | Not specified | Not specified |
| - Intelligent Tracking Tip | Included (ensures selectable overlap) | Not specified | Not specified |
Note: The "acceptance criteria" here are inferred to be the characteristics of the predicate devices which the CLARITY II aims to match or demonstrate non-significant difference from, to achieve substantial equivalence. No explicit performance metrics or thresholds are stated as "acceptance criteria."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. The submission states: "No performance data has been provided since the CLARITY II Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness." This indicates that no new clinical study with a test set was conducted for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. No clinical test set or ground truth determination is described in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No clinical test set or adjudication method is described.
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 / Not Provided. This device is a laser system and not an AI diagnostic tool that would typically undergo an MRMC study related to human reader performance with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This device is a physical laser system, not an algorithm, so "standalone performance" in the context of an algorithm is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. No clinical ground truth determination is described as no new clinical studies were submitted.
8. The sample size for the training set
- Not Applicable / Not Provided. This submission does not describe a training set as it's not an AI/ML algorithm submission.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As no training set is described, no ground truth establishment for it is mentioned.
Additional Information from the Document:
- Bench Testing: The device complies with applicable standards: ISO 13485:2016, ISO 60601-1 (electrical safety), and IEC 60601-1-2 (electromagnetic compatibility). These are considered part of the performance data to demonstrate safety and effectiveness for substantial equivalence.
- Clinical Testing: The document explicitly states: "No performance data has been provided since the CLARITY II Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness." This means the submission relies on the established safety and effectiveness of the predicate devices.
- Differences from Predicates: The CLARITY II includes a skin temperature monitoring feature (for informational purposes only) and an Intelligent Tracking Tip (ensures selectable overlap of contiguous pulses). The submission argues these differences "do not affect the safety and effectiveness of the subject device."
§ 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.