510(k) · Cleared
ClearedFamily of Coolglide Aesthetic Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cutera, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 6, 2013 as substantially equivalent to K023954 (Altus Medical, Inc., 2003) and 1 other predicate after a 144-day review. Its family tree reaches back 10 generations to 1992. 36 later devices descend from it.
- Decided
- Dec 6, 2013
- Review
- 144 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K910422 (1992). 64 ancestors in all, the oldest K892514 (1990). 36 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 1 generation backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- This deviceK132185 Family of Coolglide Aesthetic LasersCutera, Inc. · 2013
- Descendant · cites it directly · 32 of its ownK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- Descendant · cites it directly · 24 of its ownK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- Descendant · 2 generations on · 22 of its ownK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- Descendant · 3 generations on · 14 of its ownK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK183156 V-LaserWontech Co., Ltd. · 2019
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 1 generation backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- This deviceK132185 Family of Coolglide Aesthetic LasersCutera, Inc. · 2013
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K153671Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016 · cites it directly32descendants
- K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc. · 2017 · cites it directly24descendants
- K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc. · 2018 · 2 generations on22descendants
- K222064The Alma Soprano TitaniumAlma Lasers, Inc. · 2022 · 3 generations on14descendants
- K183156V-LaserWontech Co., Ltd. · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −2 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| −1 | K112715 | Candela Gentlemax Family of Lasers | Candela Corp. | 2011 | — |
| 0 (this device) | K132185 | Family of Coolglide Aesthetic Lasers | Cutera, Inc. | 2013 | — |
| +1 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
| +1 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology… | Alma Lasers, Inc. | 2017 | — |
| +2 | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| +3 | K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022 | — |
| +2 | K183156 | V-Laser | Wontech Co., Ltd. | 2019 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary page 1…878-48 Legally Marketed Predicate Family of Altus Medical CoolGlide Aesthetic Lasers with Device: Optional Pulsed Light Handpiece (K023954) Candela GentleMAX Family of Laser Systems (K1 12715) Description of the Family of… | 2003 |
| * | K112715 | Candela Gentlemax Family of LasersSummary page 1…asers with Device: Optional Pulsed Light Handpiece (K023954) Candela GentleMAX Family of Laser Systems (K1 12715) Description of the Family of The Cutera Family of CoolGlide Aesthetic Lasers comprises CoolGlide Aesthetic Lasers:… | 2011 |
What descends from it? (36)
See all 363 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 21 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 64 ancestors have a recall of any class.
- Of its descendants, K153671 (Cutera, Inc., 2016) has gone furthest, with 32 descendants of its own.
- 18 other devices also cite its predicate K023954.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The Cutera Family of CoolGlide Aesthetic Lasers is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 755 nm: The Family of CoolGlide Aesthetic Lasers is indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as tong-term, stable reduction in hair counts observed atS6, 9,and 12…
Read the full statement (550 words)
The Cutera Family of CoolGlide Aesthetic Lasers is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
755 nm:
The Family of CoolGlide Aesthetic Lasers is indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as tong-term, stable reduction in hair counts observed atS6, 9,and 12 months after the end of a treatment regime.
The Family of CoolGlide Aesthetic Lasers is also indicated for:
o treatment of benign pigmented lesions
o treatment of wrinkles
ol photocoagulation of dermatological vascular lesions such as, but not limited to, port wine stains, hemangiomas and telangiectasias
1064 nm:
Dermatology:
The Family of CoolGlide Aesthetic Lasers is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rossosa, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as, but not limited to, 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 soots), solar lentigos (sun spots), caf4 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 CoodGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The CoolGlide lasers are indicated for temporary and permanent hair reduction. Permanent hair reduction isdefined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The CoolGlide lasers are also indicated for the treatment for pseudofolliculitis barbas (PFB).
The 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 CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the CoolGlide laser handpiece isto provide coaling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Surgical Applications:
The lasers are indicated for the incision/excision and cuffing, ablation, coagulationlhemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and necktotorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
532 nm:
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, cafd-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
Optional Pulsed Light Haridpiece:
For the treatment of benign pigmented lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132185 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132185: Family of Coolglide Aesthetic Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132185
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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