510(k) · Cleared
ClearedBM.Iris
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bluecore Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Sep 8, 2017 as substantially equivalent to K113588 (Lutronic Corporation, 2012) after a 95-day review. Its family tree reaches back 13 generations to 1992. 2 later devices descend from it.
- Decided
- Sep 8, 2017
- Review
- 95 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K910422 (1992). 129 ancestors in all, the oldest K820106 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations between
- 3 generations backK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- 2 generations backK103455 Spectra Laser SystemLutronic Corporation · 2011
- 1 generation backK113588 Spectra Laser SystemLutronic Corporation · 2012
- This deviceK171648 BM.IrisBluecore Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK221789 IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK212082 PicoreBio-Med USA, Inc. · 2021
Show all 13 generations
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 11 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 10 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 9 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 8 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 7 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 6 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 5 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 4 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 3 generations backK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- 2 generations backK103455 Spectra Laser SystemLutronic Corporation · 2011
- 1 generation backK113588 Spectra Laser SystemLutronic Corporation · 2012
- This deviceK171648 BM.IrisBluecore Co., Ltd. · 2017
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 |
|---|---|---|---|---|---|
| −13 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −12 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −11 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −10 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −9 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −8 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −7 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −6 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −5 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −4 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| −3 | K083889 | Fotona QX ND:Yag/KTP Laser System Family | Fotona D.D. | 2009 | — |
| −2 | K103455 | Spectra Laser System | Lutronic Corporation | 2011 | — |
| −1 | K113588 | Spectra Laser System | Lutronic Corporation | 2012 | — |
| 0 (this device) | K171648 | BM.Iris | Bluecore Co., Ltd. | 2017 | — |
| +1 | K221789 | IRIS Pi Q switched Nd YAG laser | Bio-Med USA, Inc. | 2022 | — |
| +1 | K212082 | Picore | Bio-Med USA, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 13 | 0 |
| 2001 | 11 | 0 |
| 2002 | 16 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K113588 | Spectra Laser SystemSummary page 4…astic Surgery. Product Code : GEX Type of submission : Traditional 4. Legally marketed Predicate Device K113588 Spectra Nd:YAG Lutronic Corp BM.IRIS Q-Switched Nd:YAG laser system produce same two… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 129 ancestors have a recall of any class.
- Of its descendants, K221789 (Bio-Med USA, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K113588.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
IRIS Q-switched Nd : YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength Tattoo removal light ink (red, tan, purple, orange, sky blue,) Removal of Benign Epidermal Pigmented Lesions, Minor Benign Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses…
Read the full statement (109 words)
IRIS Q-switched Nd : YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength
Tattoo removal light ink (red, tan, purple, orange, sky blue,)
Removal of Benign Epidermal Pigmented Lesions, Minor Benign Vascular Lesions,
Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses,
Becker's Nevi, Freckles
Treatment of Post Inflammatory Hyperpigmentation (PIH)
1064nm Wavelength:
Tattoo removal: dark ink (black, blue, green )
Removal of Nevus of Ota
Removal or lightening of unwanted hair with or without adjuvant preparation
Treatment of Common Nevi, Melasma,
Skin resurfacing procedures for the treatment of acne scars, wrinkle
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171648: BM.Iris.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171648
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