510(k) · Cleared
ClearedACCENTO / HWA Dual/Single laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bison Medical Co, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Apr 22, 2016 as substantially equivalent to K130199 (Lutronic Corporation, 2013) after an 84-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Apr 22, 2016
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K910422 (1992). 65 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations between
- 3 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 2 generations backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- 1 generation backK130199 Clarity LPC Laser SystemLutronic Corporation · 2013
- This deviceK160227 ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd. · 2016
Show all 11 generations
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 7 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 6 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 5 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 4 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 3 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 2 generations backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- 1 generation backK130199 Clarity LPC Laser SystemLutronic Corporation · 2013
- This deviceK160227 ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −10 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −8 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −7 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −6 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −5 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −4 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −3 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| −2 | K112715 | Candela Gentlemax Family of Lasers | Candela Corp. | 2011 | — |
| −1 | K130199 | Clarity LPC Laser System | Lutronic Corporation | 2013 | — |
| 0 (this device) | K160227 | ACCENTO / HWA Dual/Single laser | Bison Medical Co, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K130199 | Clarity LPC Laser SystemSummary page 5…Classification Panel : General and Plastic Surgery. Product Code : GEX 4. Legally marketed Predicate Device K130199 CLARITY LPC Alexandrite and Nd:YAG Combined laser Lutronic Corp ACCENTO Alexandrite and Nd: YAG Long p… | 2013 |
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?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 65 ancestors have a recall of any class.
- 2 other devices also cite its predicate K130199.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 ACCENTO single laser system is indicated for the following: 755 nm Long pulsed Alexandrite laser Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions ( such as port of wine stains, hemangiomas, telangiectasias) Permanent hair reduction is defined as the long term…
Read the full statement (295 words)
The ACCENTO single laser system is indicated for the following:
755 nm Long pulsed Alexandrite laser
Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions ( such as port of wine stains, hemangiomas, telangiectasias)
Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6, 9,and 12 months after the completion of a treatment regime.
The ACCENTO combined laser system is indicated for the following:
755 nm Long pulsed Alexandrite laser
Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions ( such as portofwine stains, hemangiomas, telangiectasias)
1064nm Long pulsed Nd:YAG laser
the removal of un-wanted hair reduction, for stable long term or permanent hair reduction and for treatment of PFB to all skin type Fitzpatrick I-VI including tanned skin.
Treatment of Photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stain, hemangiomna, warts, telangiectasia, rosacea, venus lake, legveins and spider veins. Coagulation and hemostasis of soft tissue, Benign pigmented lesions such as lentigos (age spot) Solar lentigos ( sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae skin tags, keratoses, tattoo reduction (dart color) and plaques.
Pigmented lesions to reduce lesion size and patients with lesions, reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of scar,
Treatment of wrinkle.
Permanent hair reduction is defined as the long ferm, stable reduction in the number of hairs re-growing when measured at 6, 9,and 12 months after the completion of a treatment regime.
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/K160227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160227: ACCENTO / HWA Dual/Single laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160227
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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