RoboMarker-Refurbished - Refurbished corneal marker handle for use with TPS and IRT series marking tips.
2022-11-30
SURGILUM
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010669103 | 3010669103 | SURGILUM | 1 | N | 2026-01-01 | 2 North Front Street Floor 5 Wilmington NC US 28401 |
Registered Device Listings#
| Registration key | Listing key |
|---|---|
| 167022 | 1432822862 |
| 167022 | 1672500593 |
| 167022 | 2064567697 |
GUDID#
RoboTip G2 - A sterile device intended to be fitted to the RoboMarker G2 (Corneal Marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure that can be seen under infrared lighting. It is a small device preloaded with ink. This is a single-use, sterile device.
2022-08-08
RoboMarker G2 - A manually-operated instrument intended to be used with a disposable handpiece tip (no included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-leveling mechanism intended to accept the ink-loaded tip; it include a battery powered fixation light intended to draw the patient's focus and a projected laser target to assist with accuracy during the marking procedure. It is not intended to directly contact the eye. This is a reusable device.
2022-08-02
Surgilum - A sterile device intended to be fitted to the RoboMarker (corneal marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure that can be seen under infrared lighting. It is a small device preloaded with ink. this is a single-use device.
2021-09-21
Surgilum - A sterile device intended to be fitted to the RoboMarker (corneal marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a small device preloaded with ink. This is a single-use device.
2020-10-12
Surgilum - A manually-operated instrument intended to be used with a disposable handpiece tip (not included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-levelling mechanism intended to accept the ink-loaded tip; it includes a battery-powered fixation light intended to draw the patient’s focus during the marking procedure. It is not intended to directly contact the eye. This is a reusable device.
2020-10-01