510(k) · Cleared
ClearedORION
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yerim Engineering Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Aug 26, 2016 as substantially equivalent to K014040 (Altus Medical, Inc., 2002) and 2 other predicates after an 86-day review. Its family tree reaches back 11 generations to 1992. 1 later device descends from it.
- Decided
- Aug 26, 2016
- Review
- 86 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K910422 (1992). 65 ancestors in all, the oldest K892514 (1990). 1 later device descends from it, 1 citing it directly.
- 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 deviceK161503 ORIONYerim Engineering Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK180224 Element-TLElemenic Co., Ltd. · 2018
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 deviceK161503 ORIONYerim Engineering Co., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K180224Element-TLElemenic Co., Ltd. · 2018 · cites it directly0descendants
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) | K161503 | ORION | Yerim Engineering Co., Ltd. | 2016 | — |
| +1 | K180224 | Element-TL | Elemenic Co., Ltd. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Summary page 5…Code: GEX 4. Predicate Device: Primary Predicate Device: Family of Altus Medical Modified Cool Glide Aesthetic Lasers by Altus Medical, Inc. (K014040) Reference Predicate Device: Cynosure Apogee Elite Laser by CYNOSURE, INC. (K034030) CLARITY LPC Laser System… | 2002 |
| * | K034030 | Apogee EliteSummary page 5…us Medical Modified Cool Glide Aesthetic Lasers by Altus Medical, Inc. (K014040) Reference Predicate Device: Cynosure Apogee Elite Laser by CYNOSURE, INC. (K034030) CLARITY LPC Laser System by Lutronic Corporation (K130199) 1 === Page 6 =… | 2004 |
| * | K130199 | Clarity LPC Laser SystemSummary page 5…Inc. (K014040) Reference Predicate Device: Cynosure Apogee Elite Laser by CYNOSURE, INC. (K034030) CLARITY LPC Laser System by Lutronic Corporation (K130199) 1 5. Device Description: The subject device is composed… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180224 | Element-TL | 2018 | 0 |
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.
- Of its descendants, K180224 (Elemenic Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K014040.
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?
532nm The ORION is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions[angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias,venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques…
Read the full statement (321 words)
532nm
The ORION is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions[angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias,venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneouslesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
755 nm
The ORION is indicated for stable long-term, or permanent hair reduction which is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I- VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm
The ORION is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as,but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent hair reduction which is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161503 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161503: ORION.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161503
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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