LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
FDA 510(k) clearance K003512 · decided 2001-02-08
Clearance details
- K-number
- K003512
- Device name
- LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
- Applicant
- A.R.C. Laser AG
- Decision
- Substantially Equivalent
- Date received
- 2000-11-14
- Decision date
- 2001-02-08
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.