← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K964497 # CERALAS DIODE LASER SYSTEM (CERALAS D15) (K964497) _Ceram Optec, Inc. · GEX · Feb 6, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964497 ## Device Facts - **Applicant:** Ceram Optec, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Feb 6, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Ceralas Diode Laser System (“Ceralas D15”) is intended to be used for incision, excision, vaporization, hemostasis, and coagulation of soft tissues in open and closed (endoscopic) procedures. The Ceralas D15 is indicated for use in general surgery, urology, gynecology, neurosurgery (hemostasis), gastroenterology, plastic surgery, dermatology (vascular lesions), and otolaryngology (i.e., ear, nose, and throat (“ENT”)), including the specific ENT procedures of tonsillectomy, hemiglossectomy, vocal cord polypectomy, tracheal stenosis, polypectomy, thyroidectomy, neck dissection, and oral cavity lesions. ## Device Story Ceralas D15 is a solid-state diode laser system; utilizes gallium aluminum arsenide semiconductor diodes to generate near-infrared laser radiation (980 nm). Input: electrical power; Output: laser energy (0-15 watts) delivered via fiber optic cables with SMA-905 connectors. Used in clinical settings (OR/clinic) by physicians for soft tissue surgery. Microprocessor-controlled; features continuous or pulsed delivery modes. Aiming beam (670 nm) assists targeting. Output allows precise tissue interaction (incision/coagulation); benefits include controlled hemostasis and versatility across surgical specialties. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological characteristics and design similarities to the predicate device. ## Technological Characteristics Gallium aluminum arsenide semiconductor diodes; 980 nm wavelength (±30 nm); 0-15W power output; continuous/pulsed modes. Air-cooled with thermoelectric coolers. Fiber optic delivery (quartz core, SMA-905 connector). Microprocessor-controlled. 670 nm aiming beam (max 4 mW). ## 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 - Ceralas Diode Laser System (Model D50) ## 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} K964497 FEB - 6 1997 # 510(k) SUMMARY FOR CERAMOPTEC'S CERALAS DIODE LASER SYSTEMS (MODEL D15) ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109 Phone: (202) 637-5794 Facsimile: (202) 637-5910 as Regulatory Counsel to CeramOptec, Inc. Contact Person: same as above Date Prepared: November 5, 1996 ## Name of Device and Name/Address of Sponsor Ceralas Diode Laser Systems (Model D15) CeramOptec, Inc. 515 Shaker Road East Longmeadow, MA 01028 ## Classification Name Surgical Laser ## Predicate Device CeramOptec Inc.'s Ceralas Diode Laser System (Model D50) ## Intended Use The Ceralas Diode Laser System (“Ceralas D15”) is intended to be used for incision, excision, vaporization, hemostasis, and coagulation of soft tissues in open and closed (endoscopic) procedures. The Ceralas D15 is indicated for use in general surgery, urology, gynecology, neurosurgery (hemostasis), gastroenterology, plastic surgery, dermatology (vascular lesions), and otolaryngology (i.e., ear, nose, and throat (“ENT”)), including the specific ENT \DOC - 61213/1 - 0359825.01 {1} procedures of tonsillectomy, hemiglossectomy, vocal cord polypectomy, tracheal stenosis, polypectomy, thyroidectomy, neck dissection, and oral cavity lesions. ## Technological Characteristics and Substantial Equivalence The Ceralas D15 utilizes gallium aluminum arsenide semiconductor diodes to generate near-infrared laser radiation. The laser is air cooled with thermoelectric coolers. The exposure mode for the laser is 0-15 watts, either in a continuous or pulsed delivery mode. The Ceralas D15, like the Ceralas D50 is microprocessor controlled. The delivery systems for the Ceralas D15 consist of fiber optic cables which are fitted with an SMA-905 connector at the proximal end. The distal ends are available in a variety of configurations, including cleaved/flat or sculpted/shaped (conical, round, and chisel). The fiber optic cables are composed of a quartz fiber core with a coaxially mounted protective sheath. The cables are available with or without handpiece accessories. The Ceralas D15 has the same intended use, principles of operation, and technological characteristics as the previously cleared predicate laser system. The Ceralas D15 and the Ceralas D50 both employ a semiconductor diode to generate the treatment beam. The Ceralas D15 and D50 are both solid state lasers that emit a beam in the near-infrared region of the electromagnetic spectrum. The wavelength for the Ceralas D15 and D50 is $980 \pm 30 \mathrm{~nm}$. Both lasers offer a continuous and pulsed exposure operating mode. They also both use the same laser diode aiming beam with a $670 \mathrm{~nm}$ wavelength with an adjustable power output maximum of $4 \mathrm{mW}$. The only difference between the Ceralas D15 and D50 is the power output; the Ceralas D15 provide 0-15 watts whereas the D50 provides 0-50 watts. This modification does not raise new issues of safety or effectiveness because the cleared laser's power output range encompasses the Ceralas D15's 0-15 power output range. \DOC - 61213/1 - 0359825.01 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964497](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964497) **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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