(144 days)
Not Found
Not Found
No
The summary describes a laser system with standard controls and fiberoptic connectors, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used for surgical procedures such as incision, excision, coagulation, or vaporization of soft tissues, which are considered interventional rather than therapeutic.
No
The "Intended Use" section describes the device as being used for procedures involving incision, excision, coagulation, or vaporization of soft tissues, which are therapeutic actions, not diagnostic ones. There is no mention of the device being used to detect, identify, or monitor medical conditions.
No
The device description clearly details a physical laser system with hardware components like a laser, aiming beam, touch pad controls, power input, fiberoptic connector system, and footswitch/fingerswitch. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use of the DCL8 Enhanced Pulsed Nd: YAG laser system clearly state that it is used for surgical procedures on soft tissues within the body (incision, excision, coagulation, vaporization). This is an in vivo application, not an in vitro one.
The information provided describes a surgical laser system, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The DCL8 Enhanced Pulsed Nd: YAG laser system is substantially equivalent to other pulsed Nd: YAG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as, but not limited to: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and laparoscopic procedures.
Product codes
Not Found
Device Description
The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC). It uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems and can be operated by either a footswitch or a fingerswitch. Associated Fiberoptic Delivery Systems include NEOS Alloy Scalpels, Fiber Cap, Hybrid Surgical Device, Closed End, Closed End/Electrocautery and Bipolar Dissector, and the Fiber Contact Handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, such as, but not limited to: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SunLase Master Pulsed Nd: YAG laser system, Sunrise Technologies, Inc., SunLase Pulsed Nd: Y AG laser system, Sunrise Technologies, Inc., PulseMaster 600 Pulsed Nd: YAG laser system, American Dental Technologies, PulseMaster 1000 Pulsed Nd:YAG laser system, American Dental Technologies
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 - 3 1996 9 mm
SUMMARY OF SAFETY & EFFECTIVENESS V.
SUMMARY OF 21 CFR 807.87
- Device Name: A.
- Proprietary Name: DCL8 Enhanced Pulsed Nd:YAG 1. Laser System and Associated Fiberoptic Delivery Systems
-
- Common Name: Pulsed Nd:YAG Laser System
- B. Establishment Registration Number:
SLT-J has not yet registered as a medical device establishment with FDA. The company intends to complete all regulatory filings prior to introducing the DCL8 Enhanced Pulsed Nd: YAG laser system into interstate commerce.
Address all correspondence to: Michael D. Johnson johnson+associates 5848 Price Road Milford, OH 45150 513-248-8804
- C. Device Classification:
ﻤﺴﺘﻌﻤﺎ
Pulsed surgical Nd: YAG laser systems are currently considered Class II medical devices subject to pre-market notification provisions for many surgical applications.
Although not formally classified, Nd: YAG surgical laser delivery systems typically have been regulated as Class II devices.
1
Electrosurgery handpieces (pencils, electrodes) are considered Class II 79 GEI [21 CFR 878.4400]. SLT-J anticipates these accessory devices would receive the same classification if such delivery systems were officially classified.
Compliance With Standards D.
The DCL8 Enhanced Pulsed Nd:YAG laser system conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11, for medical laser systems. Certification reports will be submitted to CDRH certifying compliance with this standard are currently in preparation and will be submitted by SLT-J prior to commercial distribution of this product.
The sponsor is unaware of any specific standards solely for fiberoptic laser delivery systems.
E. Labeling
Product labels comply with 21 CFR 1040.10 and 1040.11 as applicable. A Operator's Manual for the DCL8 Enhanced Pulsed Nd: YAG laser system is currently in preparation. A draft Operator's Manual is included in this submission (see Section II, Device Description).
Product labels comply with 21 CFR 801 as applicable for accessory devices. Copies of the proposed text for these package labels are located in Section IV of this submission.
Promotional materials are not yet in preparation; therefore, they are not included with this submission.
2
F. Equivalence Statement
In the opinion of SLT-J, the Pulsed Nd: YAG laser system is substantially equivalent to the following systems:
SunLase Master Pulsed Nd: YAG laser system, Sunrise Technologies, Inc., (Fremont, CA)
SunLase Pulsed Nd: Y AG laser system, Sunrise Technologies, Inc. (Fremont, CA)
PulseMaster 600 Pulsed Nd: YAG laser system, American Dental Technologies (Troy, MI)
PulseMaster 1000 Pulsed Nd:YAG laser system, American Dental Technologies (Troy, MI)
- Summary of Safety and Effectiveness G.
The DCL8 Enhanced Pulsed Nd: YAG laser system is substantially equivalent to other pulsed Nd: YAG laser systems currently marketed by Sunrise Technologies (Fremont, CA) and American Dental Technologies (Trov, MI)
This belief is based upon the following facts:
- The DCL8 Enhanced Pulsed Nd:YAG laser system is 1. substantially equivalent to other pulsed Nd: YAG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as, but not limited to: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and laparoscopic procedures. The delivery systems which can be used in conjunction with the DCL8 Enhanced Pulsed Nd: YAG laser system have previously been cleared for marketing by the FDA.
3
-
- The DCL8 Enhanced Pulsed Nd: YAG laser system has the same operating characteristics as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies with respect to average power to tissue, pulse rates, operating controls and indicators. The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies.
-
- The DCL8 Enhanced Pulsed Nd:YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. This is identical to the connector systems used by Sunrise Technologies and American Dental Technologies. The delivery systems which will be used with the DCL8 Enhanced Pulsed Nd: YAG laser system have previously received market clearance for use with Nd: YAG laser systems to which the delivery systems can be attached.
- The DCL8 Enhanced Pulsed Nd: YAG laser system can be 4. operated by either a footswitch or a fingerswitch. This technology is equivalent to, and has been offered since 1990 on Nd:YAG laser systems offered by Surgical Laser Technologies (The Oaks, PA) and LCA (Cincinnati, OH), This allows the operator to select between either footswitch or fingerswitch control of the delivery system.
-
- Many of the delivery systems (NEOS Alloy Scalpels, Fiber Cap, Hybrid Surgical Device, Closed End, Closed End/Electrocautery and Bipolar Dissector) which are to be used with the DCL8 Enhanced Pulsed Nd:YAG laser system have already received market clearance for use with other Nd: Y AG laser systems. Because of the configuration of these delivery systems, i.e., delivery of laser light to tissues, the source of laser energy is not important. The delivery systems still interact
4
with tissue in a similar manner, regardless of the input (laser) source. The Super Scalpel behaves in a similar manner.
The Fiber Contact Handpiece is equivalent to those offered currently by Sunrise Technologies (Fremont, CA) and American Dental Technologies (Troy, MI) for their pulsed Nd: YAG laser systems. Additionally, Laserscope (San Jose, CA) offers an equivalent contact fiber handpiece assembly.