← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K963081 # INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS (K963081) _Indigo Medical, Inc. · GEX · Feb 21, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K963081 ## Device Facts - **Applicant:** Indigo Medical, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Feb 21, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Device Story Indigo laser system; delivers laser energy via fiber optics for surgical cutting, coagulation, and interstitial laser coagulation. Operates by elevating tissue temperature to 60-100°C to induce necrosis without carbonization. Used in clinical settings by physicians. Input: electrical power converted to laser energy; Output: thermal energy for tissue interaction. Clinical benefit: controlled tissue necrosis for surgical and gynecological procedures. Performance characterized by penetration depth in porcine tissue models (liver, kidney, heart) across varying power (5-25W) and exposure times. ## Clinical Evidence Bench testing only. In vitro study using porcine tissue (liver, kidney, heart) measured penetration depth (mm) across power settings (5-25W) and exposure times (1-5s). No human clinical data provided. ## Technological Characteristics Diode laser system; utilizes fiber optics for energy delivery. Interstitial laser coagulation modality. Operates at 60-100°C tissue temperature range. No specific materials, software, or connectivity standards provided. ## 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. ## 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} 3-15-1995 4:58AM FROM FEB 21 1997 K963081 # Section K: Summary of Safety and Effectiveness Invitro and ex vivo testing was conducted to establish equivalence to predicate devices in terms of safety and efficacy and to characterize the performance of the laser system using different types of fiber optics. When used as a general surgical instrument, the laser is able to provide power to cut or coagulate tissues. The table below shows the penetration depth in porcine tissues (in vitro) as a function of time and exposure to diode laser power. Penetration depths for other types of tissues are not presented in the table below, however tissues with similar coloration will result in similar penetration depths. For gynecological application in which it is desired to treat highly vascular endometrial tissue, liver can be used as a reference. | Exposure Power/Time | Penetration Depth (mm) | | | | --- | --- | --- | --- | | | Liver | Kidney | Heart | | 5 Watts / 1 sec | 1.73±0.20 | 1.75±0.34 | 1.77±0.37 | | 5 Watts / 2 sec | 2.48±0.73 | 2.29±0.31 | 2.19±0.62 | | 5 Watts / 5 sec | 3.37±0.64 | 3.31±0.39 | 3.03±0.72 | | 10 Watts / 1 sec | 2.26±0.47 | 1.90±0.35 | 2.25±0.62 | | 10 Watts / 2 sec | 3.30±0.59 | 2.36±0.27 | 2.16±0.35 | | 10 Watts / 5 sec | 4.34±0.78 | 3.65±0.54 | 2.89±0.34 | | 15 Watts / 1 sec | 2.35±0.45 | 2.60±0.35 | 2.16±0.32 | | 15 Watts / 2 sec | 3.61±0.50 | 3.17±0.38 | 2.58±0.34 | | 20 Watts / 1 sec | 2.99±0.48 | 2.64±0.50 | 1.99±0.36 | | 20 Watts / 2 sec | 3.27±1.34 | 2.98±0.77 | 3.48±0.79 | | 25 Watts / 1 sec | 2.81±1.13 | 2.24±0.53 | 2.96±0.83 | | 25 Watts / 2 sec | 3.65±0.72 | 3.17±1.04 | 2.81±0.44 | When used as a coagulating device, the Indigo laser in conjunction with a diffusing fiberoptic provides interstitial laser coagulation. The process of interstitial laser coagulation relies on quickly elevating tissue to a temperature range (Approx. 60 to 100°C) where tissue necrosis rapidly occurs, but below temperatures at which carbonization begins. Lesion sizes vary according to diffuser length and variation of tissue conditions. 2/6/97 GYN-SumSE --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K963081](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K963081) **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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