510(k) · Cleared
ClearedThe Friendlylight ND: Yag Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innotech USA, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 2, 2004 as substantially equivalent to K022226 (Altus Medical, Inc., 2002) and 10 other predicates after a 147-day review. Its family tree reaches back 7 generations to 1992. 519 later devices descend from it.
- Decided
- Mar 2, 2004
- Review
- 147 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 7 generations to K910422 (1992). 87 ancestors in all, the oldest K820106 (1982). 519 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 3 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 2 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 1 generation backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- This deviceK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
- Descendant · cites it directly · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 3 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
Showing 5 of 519 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 519 · See all- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · cites it directly517descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 3 generations on198descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −6 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −4 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −3 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −2 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −1 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| 0 (this device) | K033251 | The Friendlylight ND: Yag Lasers | Innotech USA, Inc. | 2004 | — |
| +1 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +2 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +3 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +3 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
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 | 7 | 0 |
| 1997 | 10 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 0 |
| 2009 | 6 | 0 |
| 2010 | 14 | 0 |
| 2011 | 14 | 0 |
| 2012 | 12 | 0 |
| 2013 | 14 | 0 |
| 2014 | 20 | 0 |
| 2015 | 20 | 0 |
| 2016 | 32 | 0 |
| 2017 | 24 | 0 |
| 2018 | 25 | 0 |
| 2019 | 14 | 0 |
| 2020 | 33 | 0 |
| 2021 | 27 | 0 |
| 2022 | 42 | 0 |
| 2023 | 32 | 0 |
| 2024 | 63 | 0 |
| 2025 | 61 | 0 |
| 2026 | 38 | 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? (11)
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 |
|---|---|---|---|
| * | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Summary page 1…ntial Equivalence: The FriendlyLight® Nd:YAG Lasers are substantially equivalent to the current, legally marketed Family of Altus Medical CoolGlide® Aesthetic Lasers (k022226), Palomar Q-YAG Nd:YAG Laser System (k023967), Candela Long Pulse Nd:YAG Laser (k010104) and GentleYAG Laser System (k022951),… | 2002 |
| * | K023967 | Palomar Q-Yag ND:Yag Laser SystemSummary page 1…Lasers are substantially equivalent to the current, legally marketed Family of Altus Medical CoolGlide® Aesthetic Lasers (k022226), Palomar Q-YAG Nd:YAG Laser System (k023967), Candela Long Pulse Nd:YAG Laser (k010104) and GentleYAG Laser System (k022951), Continuum Medical Laser System (k970808 and k… | 2003 |
| * | K010104 | Candela Long Pulse ND:YagSummary page 1…current, legally marketed Family of Altus Medical CoolGlide® Aesthetic Lasers (k022226), Palomar Q-YAG Nd:YAG Laser System (k023967), Candela Long Pulse Nd:YAG Laser (k010104) and GentleYAG Laser System (k022951), Continuum Medical Laser System (k970808 and k014234), CoolTouch "Varia" and "Varia-Il" N… | 2001 |
| * | K022951 | Candela Gentle Yag Laser System, Variable Pulse YagSummary page 1…Altus Medical CoolGlide® Aesthetic Lasers (k022226), Palomar Q-YAG Nd:YAG Laser System (k023967), Candela Long Pulse Nd:YAG Laser (k010104) and GentleYAG Laser System (k022951), Continuum Medical Laser System (k970808 and k014234), CoolTouch "Varia" and "Varia-Il" Nd:YAG Surgical Laser Systems (k010316)… | 2003 |
| * | K970808 | Medlite IV Q-Switched, Frequency Doubled, ND:Yag LaserSummary page 1…(k022226), Palomar Q-YAG Nd:YAG Laser System (k023967), Candela Long Pulse Nd:YAG Laser (k010104) and GentleYAG Laser System (k022951), Continuum Medical Laser System (k970808 and k014234), CoolTouch "Varia" and "Varia-Il" Nd:YAG Surgical Laser Systems (k010316), 510(k) for the FriendlyLight® Nd:… | 1997 |
| * | K014234 | Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag LaserSummary page 1…lomar Q-YAG Nd:YAG Laser System (k023967), Candela Long Pulse Nd:YAG Laser (k010104) and GentleYAG Laser System (k022951), Continuum Medical Laser System (k970808 and k014234), CoolTouch "Varia" and "Varia-Il" Nd:YAG Surgical Laser Systems (k010316), 510(k) for the FriendlyLight® Nd:YAG Lasers… | 2002 |
| * | K010316 | Cooltouch Varia ND:Yag Laser System; Cooltouch Varia-II ND:Yag Laser SystemSummary page 1…r (k010104) and GentleYAG Laser System (k022951), Continuum Medical Laser System (k970808 and k014234), CoolTouch "Varia" and "Varia-Il" Nd:YAG Surgical Laser Systems (k010316), 510(k) for the FriendlyLight® Nd:YAG Lasers… | 2001 |
| * | K001704 | ATHOSSummary page 3…inuum Medical Laser System (k970808 and k014234), CoolTouch "Varia" and "Varia-1l" Nd:YAG Surgical Laser Systems (k010316), Cosmos Medical Athos Long Pulse Nd:YAG laser (k001704), Laserscope's Lyra Surgical Laser System & Accessories (Nd:YAG configuration) (k990903 and k020021), Sciton Image Hair Removal N… | 2000 |
| * | K990903 | Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)Summary page 2…/•o 33 2!5/ 2/3 Cosmos Medical Athos Long Pulse Nd:YAG laser (kOO1704), Laserscope's Lyra Surgical Laser System & Accessories (Nd:YAG configuration) (k990903 and k020021), Sciton Image Hair Removal Nd:YAG Laser (k012552). The FriendlyLight® Nd:YAG Lasers have the same intended use and g… | 1999 |
| * | K020021 | Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Summary page 2…33 2!5/ 2/3 Cosmos Medical Athos Long Pulse Nd:YAG laser (kOO1704), Laserscope's Lyra Surgical Laser System & Accessories (Nd:YAG configuration) (k990903 and k020021), Sciton Image Hair Removal Nd:YAG Laser (k012552). The FriendlyLight® Nd:YAG Lasers have the same intended use and general and s… | 2002 |
| * | K012552 | Sciton Image Hair Removal LaserSummary page 2…Pulse Nd:YAG laser (kOO1704), Laserscope's Lyra Surgical Laser System & Accessories (Nd:YAG configuration) (k990903 and k020021), Sciton Image Hair Removal Nd:YAG Laser (k012552). The FriendlyLight® Nd:YAG Lasers have the same intended use and general and specific indications as the predicated CoolGlide® d… | 2001 |
What descends from it? (519)
See all 5192 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 12 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 87 ancestors have a recall of any class.
- Of its descendants, K042000 (Msq (M2), Ltd., 2004) has gone furthest, with 517 descendants of its own.
- 10 other devices also cite its predicate K022226.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 FriendlyLight® Nd:YAG lasers are intended to be used in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroentermology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculaplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: The FriendlyLight® Nd:YAG Laser systems are intended for the coagulation and hemostasis of…
Read the full statement (324 words)
The FriendlyLight® Nd:YAG lasers are intended to be used in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroentermology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculaplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
The FriendlyLight® Nd:YAG Laser systems are 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 lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafr 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.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The FriendlyLight® Nd:YAG lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkldes.
The FriendlyLight® Nd:YAG lasers are also indicated for the removal of unwanted hair, for stable long termn, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).
The FriendlyLight® Nd:YAG lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The FriendlyLight® Nd:YAG lasers are indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.
Surgical Application:
The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy gastroenterology, general surgery, head and neck/otorhiniolaryngology (ENT) neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary! thoracic surgery, gynecology (e.g. menorrhagia) and urology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033251 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033251: The Friendlylight ND: Yag Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033251
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