A.R.C. Laser GmbH
Bavaria, DE
A.R.C. LASER GMBH appears in FDA device records in Bavaria, DE. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for A.R.C. Laser GmbH between 2000 and 2022. The busiest year on record is 2000, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 3 |
| 2001 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220531 | FOX 810, FOX 980 | GEX | Substantially Equivalent | |
| K192272 | Wolf445nm | GEX | Substantially Equivalent | |
| K170183 | Cetus system, Cetus probe | HQE | Substantially Equivalent | |
| K161403 | A.R.C. Laser Surgical Fibers and Probes | GEX | Substantially Equivalent | |
| K091059 | FOXQ 980 LASER | GEX | Substantially Equivalent | |
| K073322 | FOX 1-980, FOX Q-1064, FOX-Q-810 | GEX | Substantially Equivalent | |
| K003512 | LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II | HQC | Substantially Equivalent | |
| K002986 | A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 | HQC | Substantially Equivalent | |
| K001511 | O-LAS OPHTHALMIC PHOTODISRUPTOR | GEX | Substantially Equivalent | |
| K993154 | LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006617841 | 3006617841 | A.R.C. LASER GMBH | BESSEMERSTRASSE 14, BAVARIA 90411 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0981-03 | A.R.C. Laser Photolysis Probe/Handpiece | Product may not have been properly sterilized. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain