Trokel /3 Gonio Laser Lens
FDA 510(k) K921414 · Ocular Instruments, Inc.
510(k) numberK921414
Submission
- Device name
- Trokel /3 Gonio Laser Lens
- Applicant
- Ocular Instruments, Inc.
Bellevue, WA, US - Received
- March 24, 1992
- Decision date
- November 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LQJ – Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
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| K923670 | Byrne Expulsive LensHJI · Traditional | 11/16/1992SE |
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Questions and answers
When was Trokel /3 Gonio Laser Lens cleared by the FDA?
Trokel /3 Gonio Laser Lens (K921414) received a 510(k) decision of Substantially Equivalent on November 16, 1992, 237 days after the submission was received.
What is the product code of K921414?
The FDA product code is LQJ – Lens, Surgical, Laser, Accesssory, Ophthalmic Laser, a Class II (moderate risk) device regulated under 21 CFR 886.4390.