(256 days)
No
The description details a traditional laser system with a foot switch and articulated arm, with no mention of AI, ML, or image processing capabilities.
Yes
The device is used for the removal of unwanted dark body hair, which is a therapeutic intervention.
No
The device is described as a surgical laser intended for the removal of unwanted dark body hair, indicating a therapeutic or procedural function rather than a diagnostic one.
No
The device description explicitly states it is a "surgical laser" with a "beam delivery system" and is administered via a "foot switch," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of unwanted dark body hair in dermatology. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a surgical laser that delivers energy to the body. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing a sample (blood, tissue, etc.)
- Providing diagnostic information
- Image processing, AI, DNN, or ML (which are often associated with image-based diagnostics)
- Input imaging modality (which would be relevant for image-based diagnostics)
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a therapeutic device used for a cosmetic/medical procedure.
N/A
Intended Use / Indications for Use
It is intended for use in dermatology for the removal of unwanted dark body hair.
Product codes
Not Found
Device Description
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.
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
physician
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
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
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Reference Device(s)
K961279, K950019, K892514, K955612
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
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
1
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.