← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K962354 # DIOMED 15, 30, 60 SURGICAL DIODE LASER (K962354) _Lifestream Int'L, Inc. · GEX · Sep 11, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962354 ## Device Facts - **Applicant:** Lifestream Int'L, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Sep 11, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Diomed Surgical Diode Laser is intended for use in delivering 15, 30, or 60 Watts of continuous wave radiation to a flexible optical fiber, for use in ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures. ## Device Story Class IV GaAlAs diode laser system; 805nm wavelength; 650nm aiming beam. Modifications to predicate Diomed 25W laser include power output scaling (15W, 30W, 60W models) and expanded soft tissue indications. 15W model utilizes eight 2W diodes; 30W model utilizes sixteen 2W diodes; 60W model utilizes sixteen 4W diodes. Power supply and cooling systems scaled accordingly; mechanical design and user interface unchanged. Used by surgeons in open and endoscopic procedures for soft tissue management. Delivers continuous wave radiation via flexible optical fiber. Clinical benefit includes precise tissue ablation, incision, and coagulation across multiple surgical specialties. ## Clinical Evidence Bench testing validated unit and system-level specifications. Canine tissue studies compared performance to existing Nd:YAG lasers, demonstrating equivalent tissue damage profiles and performance characteristics. ## Technological Characteristics Class IV GaAlAs diode laser; 805nm treatment wavelength; 650nm aiming beam. Power output: 15W, 30W, or 60W continuous wave. Delivery via flexible optical fiber. System includes scaled power supply and cooling architecture. Mechanical design and user interface consistent with predicate. ## Regulatory 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. ## Predicate Devices - Diomed 25 Surgical Diode Laser ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) Summary for Modifications to the Diomed Surgical Diode Laser SEP 11 1996 K962354 1. Date Summary Prepared June 17, 1996 2. Submitter's Name and Address Surgimedics/ESP 2828 N. Crescent Ridge Drive The Woodlands, TX 77381 Contact Person: Mr. Donald F. Hults Phone Number: (713) 363-4949 Fax Number: (713) 298-7930 3. Device Name Trade/Proprietary Name: Diomed 15 Surgical Diode Laser Diomed 30 Surgical Diode Laser Diomed 60 Surgical Diode Laser Common Name: Laser, GaAlAs - Diode 4. Predicate Device The legally marketed device to which equivalence is being claimed is: Diomed 25 Surgical Diode Laser Diomed Surgical Diode Laser 510(k) 6/17/96 Page E-1 {1} # 5. Device Description The Diomed Surgical Diode Laser is a Class IV GaAlAs (Gallium Arsenide) diode laser with a wavelength of $805\mathrm{nm}$ and a visible (aiming beam) 5 milliwatt Class IIIa diode laser with a wavelength of $650\mathrm{nm}$. The Diomed 15/30/60 Watt Surgical Diode Lasers are modifications to the maximum power output rating of the original Diomed 25 Watt Diode Surgical Laser. The modifications are in three areas: **Labeling:** The Diomed 25 Surgical Diode Laser will be renamed (relabeled) to the Diomed 30 Surgical Diode Laser. This change is being made to be consistent with the industry practice of designating a laser’s power based on the output power at the laser port rather that at the tissue site. There is no change in construction or performance of this device. **Power Output:** Two additional models will be created by doubling and halving the output power to produce the Diomed 15 15W Surgical Diode Laser and the Diomed 60 60W Surgical Diode Laser, respectively. The same basic design is retained. The 15 Watt model uses eight 2 Watt laser diodes, the 30 Watt model uses sixteen 2 Watt laser diodes, and the 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new models have been appropriately scaled, while the mechanical design and user interface remain unchanged. **Indication For Use:** The indications for the three models are expanded to include both contact and non-contact use for the following soft tissue applications: - General Surgery - Ophthalmology/Oculoplastic - Urology - Gastroenterology - Gynecology - Otorhinolaryngology - Pulmonary/Thoracic - Dermatology/Plastic Surgery - Neurosurgery (coagulation only) - Orthopedic Diomed Surgical Diode Laser 510(k) 6/17/96 Page E-2 {2} 6. Intended Use The Diomed Surgical Diode Laser is intended for use in delivering 15, 30, or 60 Watts of continuous wave radiation to a flexible optical fiber, for use in ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures. 7. Comparison of Technological Characteristics The modification replaces the Diomed 25 Surgical Diode Laser with three new models, the Diomed 15, 30, and 60 Surgical Diode Lasers. Modifications are to offer models with different maximum output powers (15, 30, and 60 Watts at the output port), in order to provide sufficient power when it is required, and to provide a more cost effective device for applications that do not require the higher power capabilities. The Diomed 25 Surgical Diode Laser currently operates with a maximum output power of 30 Watts at the output port. In addition indications for use have been expanded to include both contact and non-contact treatment of soft tissues applications for which legally marketed lasers are currently available. 8. Nonclinical Tests Used in Determination of Substantial Equivalence The design of the Diomed surgical Diode Lasers has been thoroughly validated at the unit and system level. The tests showed that all system specifications are satisfied. Canine tissue studies demonstrate equivalent performance between the Diomed Surgical Diode Laser and predicate laser systems, and concludes that tissue damage effects of the Diomed Surgical Diode Laser do not exceed those of existing Nd:YAG lasers. 9. Conclusions From Nonclinical Testing The testing of the modified devices demonstrates that the performance is substantially equivalent to the predicate device prior to the modifications. Diomed Surgical Diode Laser 510(k) 6/17/96 Page E-3 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962354](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962354) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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