510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K003512Substantially Equivalent

Laser Pack I, Laser Pack II, Phaco Pack I, Phaco Pack II

A.R.C. Laser GmbH, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003512 is the FDA 510(k) clearance record for LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II, a class II device, cleared for A.R.C. Laser AG on under FDA product code HQC (Unit, Phacofragmentation). FDA records list 10 510(k) clearances for A.R.C. Laser AG, from to . As of , FDA records show no recalls naming K003512.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
A.R.C. Laser AG 2417 S. 3850 W., Salt Lake City UT
510(k) summary
Summary
Third party review
No

Clearances, product code HQC

Trailing 12 months
3 clearances under product code HQC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260