510(k) · Cleared
ClearedEmerge Fractional Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palomar Medical Products, Inc. · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Nov 14, 2011 as substantially equivalent to K103664 (Palomar Medical Technologies, Inc., 2011) and 3 other predicates after a 138-day review. Its family tree reaches back 17 generations to 1992. 3 later devices descend from it.
- Decided
- Nov 14, 2011
- Review
- 138 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K910422 (1992). 295 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 13 generations between
- 3 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 2 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 1 generation backK103664 Primus Aesthetic PlatformPalomar Medical Technologies, Inc. · 2011
- This deviceK111840 Emerge Fractional LaserPalomar Medical Products, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK230077 LaserMENeauvia North America · 2023
- Descendant · 2 generations on · 1 of its ownK234004 Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK251699 The Botticelli (Model: Athena)Bellamia Technologies, Inc. · 2025
Show all 17 generations
- Root · 17 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 16 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 15 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 14 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 13 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 12 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 11 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 10 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 9 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 8 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 7 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 6 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 5 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 4 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 3 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 2 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 1 generation backK103664 Primus Aesthetic PlatformPalomar Medical Technologies, Inc. · 2011
- This deviceK111840 Emerge Fractional LaserPalomar Medical Products, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −16 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −15 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −14 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −13 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −12 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −11 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −10 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −9 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −8 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −7 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −6 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −5 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −4 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −3 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −2 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −1 | K103664 | Primus Aesthetic Platform | Palomar Medical Technologies, Inc. | 2011 | — |
| 0 (this device) | K111840 | Emerge Fractional Laser | Palomar Medical Products, Inc. | 2011 | — |
| +1 | K230077 | LaserME | Neauvia North America | 2023 | — |
| +2 | K234004 | Medical diode laser systems (CHARISMA, REGAL) | Reveal Lasers, Ltd. | 2025 | — |
| +3 | K251699 | The Botticelli (Model: Athena) | Bellamia Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 8 | 0 |
| 1994 | 14 | 0 |
| 1995 | 17 | 0 |
| 1996 | 20 | 0 |
| 1997 | 23 | 0 |
| 1998 | 19 | 0 |
| 1999 | 13 | 0 |
| 2000 | 20 | 0 |
| 2001 | 22 | 0 |
| 2002 | 29 | 0 |
| 2003 | 25 | 0 |
| 2004 | 14 | 0 |
| 2005 | 8 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 2 | 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 ONG? 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 ONG device
- #1 K250402 AVAVA™ Skin Treatment Systemscore 19.1 · 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? (4)
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 |
|---|---|---|---|
| * | K103664 | Primus Aesthetic PlatformSummary page 1…: GEX, ONG 3. PREDICATE DEVICES Palomar Medical Technologies, Inc. Palomar IconTM Aesthetic System Lux1440 Handpiece KI103664 Palomar Medical Technologies, Inc. LOI System (PaloVia TM) K090525 Reliant Technologies, Inc. (Now… | 2011 |
| * | K090525 | Loi SystemSummary page 1…es, Inc. Palomar IconTM Aesthetic System Lux1440 Handpiece KI103664 Palomar Medical Technologies, Inc. LOI System (PaloVia TM) K090525 Reliant Technologies, Inc. (Now Solta Medical, Inc.) Fraxel IV SR Laser System (Re:frneTM) K063 808… | 2009 |
| * | K063808 | Fraxel IV SR Laser SystemSummary page 1…gies, Inc. LOI System (PaloVia TM) K090525 Reliant Technologies, Inc. (Now Solta Medical, Inc.) Fraxel IV SR Laser System (Re:frneTM) K063 808 Solta Medical, Inc. Clear+Brilliant Laser System K110349 PALOMAR MEDICAL TECHNOLOGIES, INC.… | 2007 |
| * | K110349 | Clear+Brilliant Laser SystemSummary page 1…ogies, Inc. (Now Solta Medical, Inc.) Fraxel IV SR Laser System (Re:frneTM) K063 808 Solta Medical, Inc. Clear+Brilliant Laser System K110349 PALOMAR MEDICAL TECHNOLOGIES, INC. PAGE I OF 2 EMERGE LASER SYSTEM 4. I… | 2011 |
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 |
|---|---|---|---|
| K230077 | LaserME | 2023 | 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?
- The line of descent spans 19 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 10 of the 295 ancestors have a recall of any class.
- Of its descendants, K230077 (Neauvia North America, 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K103664.
How does its category compare?
All ONG devicesONG Powered Laser Surgical Instrument With MicrobeamFractional Output: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ONG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONG
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONG
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONG
1in 2025
MAUDE reports naming product code ONG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 4 | 176 | 1 | 3 |
| 2011 | 6 | 122 | 0 | 2 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 3 | 243 | 0 | 4 |
| 2014 | 2 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 40 |
| 2018 | 2 | — | 0 | 27 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 3 | 203 | 0 | 2 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 1 | — | 2 | 11 |
| 2025 | 4 | 97 | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Emerge Fractional Laser is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The Emerge Fractional Laser is further indicated for treatment of pigmented lesions, such as, but not limited to Ieniigos (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111840: Emerge Fractional Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111840
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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