Luxscope
FDA 510(k) K973193 · Luxtec Corp.
510(k) numberK973193
Submission
- Device name
- Luxscope
- Applicant
- Luxtec Corp.
Newton, MA, US - Received
- August 25, 1997
- Decision date
- November 21, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQF – Laser, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
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| K864383 | Luxtec, Killian and Vienna Nasal SpeculumsEQH · Traditional | 01/14/1987SE |
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Questions and answers
When was Luxscope cleared by the FDA?
Luxscope (K973193) received a 510(k) decision of Substantially Equivalent on November 21, 1997, 88 days after the submission was received.
What is the product code of K973193?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.