Laser Pack I, Laser Pack II, Phaco Pack I, Phaco Pack II
FDA 510(k) K003512 · A.R.C. Laser AG
510(k) numberK003512
Submission
- Device name
- Laser Pack I, Laser Pack II, Phaco Pack I, Phaco Pack II
- Applicant
- A.R.C. Laser AG
Salt Lake City, UT, US - Received
- November 14, 2000
- Decision date
- February 8, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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Questions and answers
When was Laser Pack I, Laser Pack II, Phaco Pack I, Phaco Pack II cleared by the FDA?
Laser Pack I, Laser Pack II, Phaco Pack I, Phaco Pack II (K003512) received a 510(k) decision of Substantially Equivalent on February 8, 2001, 86 days after the submission was received.
What is the product code of K003512?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.