510(k) · Cleared
ClearedBiosyag 50 Med
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bios S.R.L. · GEX Powered Laser Surgical Instrument
Cleared on Mar 24, 2005 as substantially equivalent to K020107 (Cynosure, Inc., 2002) after a 94-day review. Its family tree reaches back 1 generation to 2002. 3 later devices descend from it.
- Decided
- Mar 24, 2005
- Review
- 94 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020107 (2002). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK020107 SmartepilCynosure, Inc. · 2002
- This deviceK043521 Biosyag 50 MedBios S.R.L. · 2005
- Descendant · cites it directly · 2 of its ownK080374 Biosyag Medical SystemBios S.R.L. · 2008
- Descendant · 2 generations on · 1 of its ownK113018 Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice…Beijing Syntech Laser CO., LTD. · 2012
- Descendant · 3 generations on · 0 of its ownK221766 SolonLmg Lasers Comercio, Importacao E Exportacao Ltda · 2024
Most influential descendants
Showing 3 of 3 · See all- K080374Biosyag Medical SystemBios S.R.L. · 2008 · cites it directly2descendants
- K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD. · 2012 · 2 generations on1descendant
- K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020107 | Smartepil | Cynosure, Inc. | 2002 | — |
| 0 (this device) | K043521 | Biosyag 50 Med | Bios S.R.L. | 2005 | — |
| +1 | K080374 | Biosyag Medical System | Bios S.R.L. | 2008 | — |
| +2 | K113018 | Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light… | Beijing Syntech Laser CO., LTD. | 2012 | — |
| +3 | K221766 | Solon | Lmg Lasers Comercio, Importacao E Exportacao Ltda | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 1 | 0 |
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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K020107 | SmartepilSummary page 1…ame: Instrument, surgical, powered, laser 79 -GEX 21 CFR 878.4810 Equivalent Device: Cynosure Smartepil (K020107) Device Description: The BIOSYAG 50 Med laser is a pulse Nd: YAG laser utilizing the Nd:YAG cry… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080374 | Biosyag Medical System | 2008 | 2 |
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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The BIOSYAG 50 Med laser is indicated for benign vascular lesions and hair removal.
The equipment should only be used under medical supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043521: Biosyag 50 Med.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043521
Report an extraction error
Are you the manufacturer?
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