Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) → LNK — Laser For Gastro-Urology Use # LNK · Laser For Gastro-Urology Use _General, Plastic Surgery · 21 CFR 878.4810 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK ## Overview - **Product Code:** LNK - **Device Name:** Laser For Gastro-Urology Use - **Regulation:** [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **3rd-party reviewable:** yes ## 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. ## Classification Rationale (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. ## Recent Cleared Devices (20 of 60) Showing 20 most recent of 60 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K925395](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K925395.md) | TECHNOMED PULSOLITH 4000 LASER SYSTEM | Teknomed, Inc. | May 21, 1993 | SESE | | [K901723](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K901723.md) | MDL-2000 LASERTRIPTER | Candela Laser Corp. | Jul 13, 1990 | SESE | | [K874255](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K874255.md) | ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. | Minnesota Laser Corp. | Jul 12, 1988 | SESE | | [K874253](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K874253.md) | ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. | Minnesota Laser Corp. | Jul 12, 1988 | SESE | | [K880256](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K880256.md) | MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE | Sharplan Lasers, Inc. | Apr 14, 1988 | SESE | | [K880193](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K880193.md) | MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE | Sharplan Lasers, Inc. | Apr 14, 1988 | SESE | | [K875039](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K875039.md) | ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY | Surgilase, Inc. | Apr 13, 1988 | SESE | | [K880171](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K880171.md) | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | Cooper Lasersonics, Inc. | Apr 11, 1988 | SESE | | [K871934](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K871934.md) | MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE | Lasermatic, Inc. | Mar 25, 1988 | SESE | | [K871932](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K871932.md) | MODEL 5050 SURGILASER FOR UROLOGY USE | Lasermatic, Inc. | Mar 25, 1988 | SESE | | [K873892](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K873892.md) | SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE | Laserguide | Feb 2, 1988 | SESE | | [K873330](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K873330.md) | KTP/532 LASER | Laserscope | Nov 18, 1987 | SESE | | [K872870](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K872870.md) | LASER OPTICAL FIBERS - DISPOSABLE | Optimed Therapeutics | Oct 14, 1987 | SESE | | [K871865](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K871865.md) | SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE | Sharplan Lasers, Inc. | Sep 8, 1987 | SESE | | [K872630](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K872630.md) | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. | Hgm, Inc. | Aug 25, 1987 | SESE | | [K872350](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K872350.md) | FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE | Laser Media | Aug 10, 1987 | SESE | | [K872031](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K872031.md) | UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM | Laser Media | Aug 4, 1987 | SESE | | [K871516](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K871516.md) | SL-100 ND:YAG LASER FOR UROLOGIC SURGERY | Medical Energy, Inc. | Jul 9, 1987 | SESE | | [K871515](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K871515.md) | SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING | Medical Energy, Inc. | Jul 9, 1987 | SESE | | [K871514](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK/K871514.md) | SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID | Medical Energy, Inc. | Jul 9, 1987 | SESE | ## Top Applicants - Cooper Lasersonics, Inc. — 8 clearances - Laser Media — 8 clearances - Endo Lase, Inc. — 6 clearances - Directed Energy, Inc. — 4 clearances - Medical Energy, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LNK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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