510(k) · Cleared
ClearedLoi System
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 Jun 1, 2009 as substantially equivalent to K072459 (Photo Therapeutics, Inc., 2008) and 2 other predicates after a 95-day review. Its family tree reaches back 12 generations to 1992. 9 later devices descend from it.
- Decided
- Jun 1, 2009
- Review
- 95 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K910422 (1992). 170 ancestors in all, the oldest K800617 (1980). 9 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 2 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- This deviceK090525 Loi SystemPalomar Medical Products, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK111840 Emerge Fractional LaserPalomar Medical Products, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK230077 LaserMENeauvia North America · 2023
- Descendant · 3 generations on · 1 of its ownK234004 Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK163137 NIRA Beauty Skin LaserDermal Photonics Corporation · 2017
- Descendant · cites it directly · 1 of its ownK130459 Tria Fan SystemTria Beauty, Inc. · 2013
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 7 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 6 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 5 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 4 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 3 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 2 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- This deviceK090525 Loi SystemPalomar Medical Products, Inc. · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K111840Emerge Fractional LaserPalomar Medical Products, Inc. · 2011 · cites it directly3descendants
- K230077LaserMENeauvia North America · 2023 · 2 generations on2descendants
- K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd. · 2025 · 3 generations on1descendant
- K163137NIRA Beauty Skin LaserDermal Photonics Corporation · 2017 · cites it directly1descendant
- K130459Tria Fan SystemTria Beauty, Inc. · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −7 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −6 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −5 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −4 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −3 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −2 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −1 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| 0 (this device) | K090525 | Loi System | Palomar Medical Products, Inc. | 2009 | — |
| +1 | K111840 | Emerge Fractional Laser | Palomar Medical Products, Inc. | 2011 | — |
| +2 | K230077 | LaserME | Neauvia North America | 2023 | — |
| +3 | K234004 | Medical diode laser systems (CHARISMA, REGAL) | Reveal Lasers, Ltd. | 2025 | — |
| +1 | K163137 | NIRA Beauty Skin Laser | Dermal Photonics Corporation | 2017 | — |
| +1 | K130459 | Tria Fan System | Tria Beauty, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 5 | 0 |
| 1994 | 13 | 0 |
| 1995 | 13 | 0 |
| 1996 | 18 | 0 |
| 1997 | 18 | 0 |
| 1998 | 14 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 9 | 0 |
| 2002 | 13 | 0 |
| 2003 | 11 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K072459 | Omnilux New-USummary page 1…21 CFR §878.4810) PRODUCT CODE: OHS, GEX 3. PREDICATE DEVICES Photo Therapeutics, Inc. Omnilux New-UTM K072459 Light Biosciences, LLC GentleWaves® Consumer LED Photomodulation Device K062991 PALOMAR MEDICAL… | 2008 |
| * | K062991 | Gentlewaves Consumer Led Photomodulation DeviceSummary page 1…oto Therapeutics, Inc. Omnilux New-UTM K072459 Light Biosciences, LLC GentleWaves® Consumer LED Photomodulation Device K062991 PALOMAR MEDICAL TECHNOLOGIES, INC. PAGE 1 OF 2 LOI SYSTEM: TRADITIONAL 5 10O(K) ===… | 2008 |
| * | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System)Summary page 2…PAGE 1 OF 2 LOI SYSTEM: TRADITIONAL 5 10O(K) Reliant Technologies, Inc. Fraxel Laser System (Fraxel SR1500, Re:storeTM) K070284 4. INTENDED USE The LOI System is an over-the-counter device intended for treatment of periorbital wrinkles. 5.… | 2007 |
What descends from it? (9)
4 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 17 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 170 ancestors have a recall of any class.
- Of its descendants, K111840 (Palomar Medical Products, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K072459.
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. 2009, 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 LOI System is an over-the-counter device intended for treatment of periorbital wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090525: Loi System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090525
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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