510(k) · Cleared
ClearedBiosyag Medical System
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 May 15, 2008 as substantially equivalent to K043521 (Bios S.R.L., 2005) and 1 other predicate after a 93-day review. Its family tree reaches back 10 generations to 1992. 2 later devices descend from it.
- Decided
- May 15, 2008
- Review
- 93 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K910422 (1992). 157 ancestors in all, the oldest K820106 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- 1 generation backK072344 Apl Medical SystemBios S.R.L. · 2007
- This deviceK080374 Biosyag Medical SystemBios S.R.L. · 2008
- Descendant · cites it directly · 1 of its ownK113018 Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice…Beijing Syntech Laser CO., LTD. · 2012
- Descendant · 2 generations on · 0 of its ownK221766 SolonLmg Lasers Comercio, Importacao E Exportacao Ltda · 2024
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- 1 generation backK072344 Apl Medical SystemBios S.R.L. · 2007
- This deviceK080374 Biosyag Medical SystemBios S.R.L. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| −1 | K072344 | Apl Medical System | Bios S.R.L. | 2007 | — |
| 0 (this device) | K080374 | Biosyag Medical System | Bios S.R.L. | 2008 | — |
| +1 | K113018 | Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light… | Beijing Syntech Laser CO., LTD. | 2012 | — |
| +2 | K221766 | Solon | Lmg Lasers Comercio, Importacao E Exportacao Ltda | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 8 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 12 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 15 | 0 |
| 2001 | 19 | 0 |
| 2002 | 23 | 0 |
| 2003 | 14 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K043521 | Biosyag 50 MedSummary page 1…and FTC 21 CFR 878.4810 and 21 CFR 878.4630 Equivalent Device: BIOS ITALIA S.R.L. · Bios Yag 50 Med- 510(k) n°: K043521 * APL Medical System - 510(k) n°: K072344 Device Description: The BIOSYAG MEDICAL SYSTEM is a mod… | 2005 |
| * | K072344 | Apl Medical SystemSummary page 1…Equivalent Device: BIOS ITALIA S.R.L. · Bios Yag 50 Med- 510(k) n°: K043521 * APL Medical System - 510(k) n°: K072344 Device Description: The BIOSYAG MEDICAL SYSTEM is a modular multi- laser and multi-use device for… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113018 | Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based Platform | 2012 | 1 |
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?
- The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 157 ancestors have a recall of any class.
- Of its descendants, K113018 (Beijing Syntech Laser CO., LTD., 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 MEDICAL SYSTEM is a modular multi-laser and multi-use device for the cosmetic treatment of face and body. It is used to treat common imperfections and lesions of skin and body, including: 1. The removal of unwanted hair and to effect stable long term or permanent hair reduction, 2. Laser skin treatment procedures for the treatment of: * acne scars · wrinkles 3. Incision, excision, ablation, vaporisation of soft tissue, 4. The non-ablative…
Read the full statement (149 words)
The BIOSYAG MEDICAL SYSTEM is a modular multi-laser and multi-use device for the
cosmetic treatment of face and body. It is used to treat common imperfections and lesions of
skin and body, including:
1. The removal of unwanted hair and to effect stable long term or permanent hair
reduction,
2. Laser skin treatment procedures for the treatment of:
* acne scars
· wrinkles
3. Incision, excision, ablation, vaporisation of soft tissue,
4. The non-ablative treatment of facial wrinkles, such as, but not limited to:
* periocular wrinkles
· perioral wrinkles
5. Removal of tattoos and blemishes of the skin, the treatment of various pigmentation
lesions.
6. Treatment of capillaries, teleangiectasies and vascular lesions.
7. Treatment of vitiligo and psoriasis.
The correlation between type of light source, wavelength, and intended use is outlined in the
table displayed on the following page.
The equipment should only be used under medical supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080374: Biosyag Medical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080374
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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