SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS

K871511 · Medical Energy, Inc. · LLO · Jul 21, 1987 · Ear, Nose, Throat

Device Facts

Record IDK871511
Device NameSL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
ApplicantMedical Energy, Inc.
Product CodeLLO · Ear, Nose, Throat
Decision DateJul 21, 1987
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 874.4500
Device ClassClass 2

Regulatory Classification

Identification

An ear, nose, and throat microsurgical carbon dioxide laser is a device intended for the surgical excision of tissue from the ear, nose, and throat area. The device is used, for example, in microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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