510(k) · Cleared
ClearedBQ/BM Integrated Laser Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Laser Corp. · HQF Laser, Ophthalmic
Cleared on May 17, 1999 as substantially equivalent to K973220 (G. Rodenstock Instrumente GmbH, 1997) after a 76-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- May 17, 1999
- Review
- 76 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973220 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK973220 Rodenstock Laser SlitlampG. Rodenstock Instrumente GmbH · 1997
- This deviceK990665 BQ/BM Integrated Laser Delivery SystemAmerican Laser Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973220 | Rodenstock Laser Slitlamp | G. Rodenstock Instrumente GmbH | 1997 | — |
| 0 (this device) | K990665 | BQ/BM Integrated Laser Delivery System | American Laser Corp. | 1999 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973220 | Rodenstock Laser SlitlampSummary page 1…ct Code: 86 HJQ Predicate Devices: The BQ/BM Integrated Laser Delivery System is substantially equivalent to the following legally marketed devices: The RO 5000 AR/FDY (K973220) manufactured by G. Rodenstock Instrumente GmbH and the Zeiss 130 SL Laser Slit Lamp manufactured by Carl Zeiss. Device Descript… | 1997 |
| * | — | Zeiss 130 SL Laser Slit Lamp Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
1. RETINAL PHOTOCOAGULATION
2. TRABECULOPLASTY
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990665: BQ/BM Integrated Laser Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990665
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026