(256 days)
It is intended for use in dermatology for the removal of unwanted dark body hair.
The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed (O-Switched or Free Running) laser energy of a 694.3 nm wavelength through an articulated arm beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.
The Sharplan Lasers, Inc. Ruby Laser System is intended for use in dermatology for the removal of unwanted dark body hair. The submission does not specify quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices and presenting clinical data to support safety and efficacy.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicit) | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative acceptance criteria in the provided text. | Clinical data on 31 patients with a 3-month follow-up period demonstrating "safety and efficacy." The specific metrics for efficacy (e.g., percentage of hair reduction, duration of hair reduction) are not provided. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 31 patients.
- Data Provenance: The document does not specify the country of origin of the data. It is a prospective clinical study as it involved a 3-month follow-up period.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not provided in the document. The study described is a clinical trial, but details about expert assessment of hair removal outcomes (e.g., by dermatologists or other specialists) and their qualifications are absent.
4. Adjudication Method for the Test Set:
- This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This submission describes a clinical study to demonstrate the performance of the device itself, not a comparative study of human readers with and without AI assistance.
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 AI algorithm. Its performance is directly tied to its physical operation and effect on patients.
7. The Type of Ground Truth Used:
- The ground truth referred to implicitly by "safety and efficacy" would be clinical outcomes (e.g., observed hair removal, adverse events) as assessed during the 3-month follow-up period. However, the specific metrics and how they were measured are not detailed.
8. The Sample Size for the Training Set:
- Not applicable. This is a hardware device, not a machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. See point 8.
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MAR -7 1997 K962446
510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. Ruby Laser System
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Sharplan Lasers, Inc. Ruby Laser System is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Sharplan Ruby Laser, the ThermoLase LT-100 Q-Switched Nd: Y AG Laser, the American Hair Removal System, and the Spectrum EpiLaser (Ruby) System.
1 . Firm:
Sharplan Lasers, Inc. 1 Pearl Court Allendale, NJ ()74()1 December 6, 1996 George J. Hattub, Director of Regulatory Affairs 1-800-394-2000. ext. 531
2. Model:
Sharplan Lasers, Inc. Ruby Laser System (for Hair Removal Indication)
Predicate Devices: 3.
The Sharplan Ruby Laser, the ThermoLase LT-100) O-Switched Nd: Y AG Laser, the American Hair Removal System, and the Spectrum EpiLaser (Ruby) System.
Description: 4 .
The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed (O-Switched or Free Running) laser energy of a 694.3 nm wavelength through an articulated arm beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.
5 . Intended Use:
The Sharplan Lasers, Inc. Ruby Laser System is substantially equivalent to the following devices: the Sharplan Ruby Laser, the ThermoLase LT-100 Q-Switched Nd: Y AG Laser, the American Hair Removal System, and the Spectrum EpiLaser (Ruby) System (K961279, K950019, K892514, and K955612 respectively). It is intended for use in dermatology for the removal of unwanted dark body hair.
Clinical data on 31 patients with a 3 month follow-up period was presented in order to demonstrate the safety and efficacy of the device
Revised December 6, 1996
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510(k) Summary of Safety and Effectiveness (continued) Sharplan Lasers, Inc. Ruby Laser System
6. Intended Use & Technological Characteristics
From a clinical performance and intended use perspective, two of the predicate devices (the ThermoLase LT 100 and the American Hair Removal System) and the candidate device, (the Sharplan Ruby Laser System) produces a similar result which is the removal of unwanted body hair. In terms of functioning characteristics, for one of the predicate devices (the Spectrum EpiLaser), and the Sharplan Ruby Laser System are of the same technology. Furthermore, they have the same operating principle, and their performance characteristics are similar. Sharplan Lasers, Inc.believes that the differences between the aforementioned devices do not raise any issues pertaining to safety or efficacy.
- This information was prepared for the sole purpose of compliance with the Advisory: Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
§ 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.