(76 days)
Not Found
No
The device description and the absence of mentions of AI, ML, or related concepts strongly suggest it is a traditional laser system without AI/ML components.
Yes
The device is intended for the removal or lightening of tattoos and pigmented lesions, which are therapeutic interventions.
No
The device is described as a "surgical laser" intended for "photothermolysis" to remove tattoos or pigmented lesions, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it is a "surgical laser" and describes hardware components like an "articulated arm beam delivery system" and a "foot switch." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for photothermolysis in dermatology to remove tattoos and pigmented lesions. 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 patient's tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a therapeutic device used to treat conditions directly on the patient.
N/A
Intended Use / Indications for Use
The Sharplan Lasers, Inc. Ruby Laser System is substantially equivalent to the following devices: the Spectrum RD-1200 Ruby Laser and Derma-Lase DLR Ruby Laser, (K910422 and K924647, respectively). It is intended for use in dermatology for photothermolysis, for the specific indications {in adults (18 years or older)} to remove blue-black tattoos, or to remove or lighten benign epidermal pigmented lesions.
Product codes
Not Found
Device Description
The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed 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
adults (18 years or older)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No new indications were sought in this premarket notification and no clinical data was presented.
physical testing of the device has demonstrated that it is similar both in function and performance to its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
JUN 18 1396
961279
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 Spectrum RD-1200 Ruby Laser and the Derma-Lase DLR Ruby Laser.
Firm: 1.
Sharplan Lasers, Inc. 1 Pearl Court Allendale, NJ 07401 April 1, 1996 George J. Hattub, Director of Regulatory Affairs 1-800-394-2000, ext. 531
2. Model:
Sharplan Lasers, Inc. Ruby Laser System
3. Predicate Devices:
The Spectrum RD-1200 Ruby Laser and the Derma-Lase DLR Ruby Laser
4 . Description:
The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed 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 Spectrum RD-1200 Ruby Laser and Derma-Lase DLR Ruby Laser, (K910422 and K924647, respectively). It is intended for use in dermatology for photothermolysis, for the specific indications {in adults (18 years or older)} to remove blue-black tattoos, or to remove or lighten benign epidermal pigmented lesions.
No new indications were sought in this premarket notification and no clinical data was presented.
REVISED JUNE 7, 1996
1
510(k) Summary of Safety and Effectiveness (continued) Sharplan Lasers, Inc. Ruby Laser System
6. Technological Characteristics
From a clinical performance perspective, the aforementioned devices produce a similar therapeutic output in terms of laser wavelength and spot size (5-8mm). Regarding the technological characteristics, while are not identical, physical testing of the device has demonstrated that it is similar both in function and performance to its predicate devices. Sharplan Lasers, Inc.believes that none of the differences of the device raise any issues pertaining to its 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.