(239 days)
Not Found
No
The description focuses on the laser technology and its physical components, with no mention of AI or ML capabilities.
Yes
The device is described as a "surgical laser system" used for the "incision, excision, ablation, vaporization, coagulation of soft tissue" in general surgery and dermatology, which are therapeutic medical procedures.
No
The device is described as a surgical laser system used for incision, excision, ablation, vaporization, and coagulation of soft tissue. These are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines a hardware-based surgical laser system with a console, fiber-optic delivery, foot switch, and key interlock. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for direct interaction with soft tissue within the body (incision, excision, ablation, vaporization, coagulation). This is an in vivo application.
- Device Description: The description details a surgical laser system that delivers a laser beam to the treatment site via a fiber optic. This is consistent with a surgical tool used on a living patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (blood, urine, tissue samples, etc.) or performing tests in vitro (in a lab setting).
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument used directly on the patient.
N/A
Intended Use / Indications for Use
For use in general surgery for the incision, excision, ablation, vaporization, coagulation of soft tissue. For use in dermatology for incision, excision, ablation and for use in doming hemostasis of soft tissue.
Product codes
GEX
Device Description
The New Star Model 130 laser is a compact, portable, self-contained surgical laser system that produces a variable 1-6 watt beam of infrared radiation at 1320nm wavelength. The system emits a pulsed laser beam which is delivered to the treatment site using a fiber optic delivery system. A visible light 0.5 mW HeNe laser beam at 632.8nm is used for aiming. The system is comprised of a laser console, a fiber-optic delivery system, a foot switch and a removable electronic key interlock. The system provides safety features that are designed to protect the operator and patient from high voltage and laser emissions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics
Not Found
Predicate Device(s)
K952489, K912703, K932376, K933322, K920106
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
K 962791
510(k) Summary
| Submitter. | New Star Lasers, Inc.
11802 Kemper Road
Auburn, California 95603
916-823-1434
916-823-1446 fax |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | David R. Hennings
President |
| Date Summary Prepared: | July 16, 1996 |
| Device Trade Name: | New Star Model 130 6-Watt Nd:YAG Laser System |
| Common Name: | Surgical laser system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Devices: | Laser.
New Star Model 600 Holmium Laser System, New Star Lasers, Inc.
(K952489) |
| | Optica 60 Nd:YAG Laser System, XINTEC Corp.
(K912703) |
| | Opmilas 144 Nd:YAG Laser System, Carl Zeiss, Inc.
(K932376, K933322) |
| | ADL 400, Sunrise Technologies, Inc.
(K920106) |
| | Optional Coolant
Gebauer Fluro-Ethyl topical refrigerant
(Pre-Amendment device) |
| Device Description: | The New Star Model 130 laser is a compact, portable, self-contained
surgical laser system that produces a variable 1-6 watt beam of infrared
radiation at 1320nm wavelength. The system emits a pulsed laser
beam which is delivered to the treatment site using a fiber optic delivery
system. A visible light 0.5 mW HeNe laser beam at 632.8nm is used for
aiming. |
| | The system is comprised of a laser console, a fiber-optic delivery
system, a foot switch and a removable electronic key interlock. The
system provides safety features that are designed to protect the
operator and patient from high voltage and laser emissions. |
| | ( |
100
!
1
510(k) Summary (cont'd)
| Intended Use: | For use in general surgery for the incision, excision, ablation,
vaporization, coagulation of soft tissue. |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | Pulse duration, pulse repetition rate, power, energy per pulse, exposure,
alming beam, beam delivery, energy monitor and fiber calibration for the
New Star Model 130 6-Watt Nd:YAG Laser System fall within the range
of values available on the referenced equivalent systems. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The New Star Model 130 6-Watt Nd:YAG Laser System is substantially
equivalent to other existing surgical laser systems in commercial
distribution for the incision, excision, ablation, vaporization and
coagulation of soft tissue. |
| Additional Information: | None requested at this time. |
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not assigned yet K 962791 510(k) Number (if known): New Star Model 130 6-watt Nd:YAG Laser System Device Name: For use in dermatology for incision, excision, ablation and Indications for Use: rol use in doming hemostatis of soft tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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