Laser Contact Lenses Cga 1, Cgi 1, CGP 1, CGV 1
FDA 510(k) K871245 · Chiron Vision Corp.
510(k) numberK871245
Submission
- Device name
- Laser Contact Lenses Cga 1, Cgi 1, CGP 1, CGV 1
- Applicant
- Chiron Vision Corp.
Irvine, CA, US - Received
- March 27, 1987
- Decision date
- May 7, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K884694 | MQL 20 Nd:Yag Ophthalmic LaserLQJ · Traditional | California Laboratories, Inc. | 11/30/1988SE |
| K883719 | Interconn. of Ophthalas & Nanolas Laser SystemLQJ · Traditional | Biophysic Medical, Inc. | 10/18/1988SE |
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| K872802 | Trokel Single Mirror Yag Laser LensLQJ · Traditional | Ocular Instruments, Inc. | 09/04/1987SE |
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| K944994 | Iolab/Site Disposable Diaphragm CassetteHQC · Traditional | 03/14/1995SE |
| K941550 | Automatic Corneal Shaper Surgical InstrumentHNO · Traditional | 11/22/1994SE |
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Questions and answers
When was Laser Contact Lenses Cga 1, Cgi 1, CGP 1, CGV 1 cleared by the FDA?
Laser Contact Lenses Cga 1, Cgi 1, CGP 1, CGV 1 (K871245) received a 510(k) decision of Substantially Equivalent on May 7, 1987, 41 days after the submission was received.
What is the product code of K871245?
The FDA product code is LQJ – Lens, Surgical, Laser, Accesssory, Ophthalmic Laser, a Class II (moderate risk) device regulated under 21 CFR 886.4390.