Panels › Ophthalmic › Product code HQE · Class 2
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Regulation 886.4150
0510(k)s in 12 months (149 all time)
3recalls in 12 months (37 all time)
35recalls that name a 510(k)
Top companies in HQE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2026 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM;
Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00; Open, Classified |
HQE | K213467 |
| Jun 5, 2026 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM;
Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201; Open, Classified |
HQE | K213467 |
| Jun 5, 2026 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM;
Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00; Open, Classified |
HQE | K213467 |
| Oct 24, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000393 UN Open, Classified |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper. Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper. Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, Terminated |
HQE | K162342 |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper. Terminated |
HQE | K162342 |
| Oct 18, 2016 | Synergetics Inc 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration. Terminated |
HQE | K121675 |
| Oct 18, 2016 | Synergetics Inc 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. Terminated |
HQE | K121675 |
| Oct 18, 2016 | Synergetics Inc 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. Terminated |
HQE | K121675 |
| Oct 18, 2016 | Synergetics Inc 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. Terminated |
HQE | K121675 |
| Jun 6, 2013 | Alcon Grieshaber AG The Constellation Vision System Pneumatic Handpiece.
Indicated for both anterior and posterior segment opthalmic surgery. Terminated |
HQE | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Angled Needle, Model BL5123A, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. Terminated |
HQE | K063331 |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Needle, Model BL5123, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The pla Terminated |
HQE | K063331 |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Angled Needle, Model BL5114A, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The Terminated |
HQE | K063331 |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Model BL5114, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic Terminated |
HQE | K063331 |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Angled Needle, Model BL5113A, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The Terminated |
HQE | K063331 |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Needle, Model BL5113, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic Terminated |
HQE | K063331 |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Basic AFS Phaco Pack, Model BL5121, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in Terminated |
HQE | K063331 |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Premium AFS Phaco Pack, Model BL5120, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained i Terminated |
HQE | K063331 |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Model BL5112, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench co Terminated |
HQE | K063331 |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Vacuum Phaco Pack, Model BL5111, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in the Terminated |
HQE | K063331 |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Model BL5110, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench containe Terminated |
HQE | K063331 |
| May 24, 2007 | Bausch & Lomb Inc Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other accessories. Catalog #USSCX4920A is also in Terminated |
HQE | K980488 |
| May 24, 2007 | Bausch & Lomb Inc Bausch & Lomb Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high speed vitrectomy cutter per package. The firm name on the label is Bausch & Lomb incorporated, Rochester, NY. Terminated |
HQE | K980488 |
| Apr 21, 2007 | Bausch & Lomb Inc Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX4925, containing 1/25-ga. cutter along with accessories, RX. The firm names on the label are Bausch & Lomb Inco Terminated |
HQE | K980488 |
| Apr 21, 2007 | Bausch & Lomb Inc Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch & Terminated |
HQE | K980488 |
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