510(k) Report

510(k) · Cleared

Cleared

Naturalase LP ND:Yag Laser

K031828510(k) TraditionalCleared Jul 17, 200334-day reviewClass I21 CFR 878.4800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Focus Medical, LLC · GEN Forceps, General & Plastic Surgery

Cleared on Jul 17, 2003 as substantially equivalent to K023954 (Altus Medical, Inc., 2003) and 8 other predicates after a 34-day review. Its family tree reaches back 7 generations to 1992. 5 later devices descend from it.

Decided
Jul 17, 2003
Review
34 days
Class
Class I
Product code
GEN
Recalls
None
Predicates
9

Its longest line of descent runs back 7 generations to K910422 (1992). 92 ancestors in all, the oldest K820106 (1982). 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 12 other ancestors2001: 10 other ancestors2000: 9 other ancestors1999: 4 other ancestors1998: 6 other ancestors1997: 9 other ancestors1996: 8 other ancestors1994: 8 other ancestors1995: 6 other ancestors1990: 1 other ancestor1993: 5 other ancestors1991: 4 other ancestors1988: 1 other ancestor1982: 1 other ancestor2004: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant clearedK910422 · Model RD-1200 Ruby Laser System · Spectrum Medical Technologies, Inc. · 1992K961279 · Sharplan Lasers, Inc. Ruby Laser System · Sharplan Lasers, Inc. · 1996K962446 · Sharplan Ruby Laser System · Sharplan Lasers, Inc. · 1997K974536 · Photoderm HR System · Esc Medical Systems, Ltd. · 1998K991935 · Epilight Hair Removal System, Photoderm HR System · Esc Medical Systems, Ltd. · 2000×2: 2 generations cleared close together, K014040 (2002), K022226 (2002) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 31 other ancestors3 generations back: 15 other ancestors4 generations back: 13 other ancestors5 generations back: 5 other ancestors6 generations back: 14 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K022226 · Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models · Altus Medical, Inc. · 2002K014040 · Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models · Altus Medical, Inc. · 2002K991935 · Epilight Hair Removal System, Photoderm HR System · Esc Medical Systems, Ltd. · 2000K974536 · Photoderm HR System · Esc Medical Systems, Ltd. · 1998K962446 · Sharplan Ruby Laser System · Sharplan Lasers, Inc. · 1997K961279 · Sharplan Lasers, Inc. Ruby Laser System · Sharplan Lasers, Inc. · 1996K910422 · Model RD-1200 Ruby Laser System · Spectrum Medical Technologies, Inc. · 1992−50+5
  1. Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
  2. 6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
  3. 5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
  4. 4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
  5. 3 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
  6. 2 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
  7. 1 generation backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
  8. This deviceK031828 Naturalase LP ND:Yag LaserFocus Medical, LLC · 2003
  9. Descendant · cites it directly · 4 of its ownK041829 Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC · 2004
  10. Descendant · 2 generations on · 3 of its ownK081219 Apollo Mini Ipl SystemSandstone Medical Technologies, LLC · 2008
  11. Descendant · 3 generations on · 2 of its ownK110304 Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011
  12. Descendant · 4 generations on · 1 of its ownK123777 Multilaser SystemUltralight Laser Technologies, LLC · 2013
  13. Descendant · 5 generations on · 0 of its ownK233143 PiXel8-RevealRohrer Aesthetics · 2024

Most influential descendants

Showing 5 of 5 · See all
  • K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC · 2004 · cites it directly4descendants
  • K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC · 2008 · 2 generations on3descendants
  • K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011 · 3 generations on2descendants
  • K123777Multilaser SystemUltralight Laser Technologies, LLC · 2013 · 4 generations on1descendant
  • K233143PiXel8-RevealRohrer Aesthetics · 2024 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K910422Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc.1992—
−6K961279Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc.1996—
−5K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc.1997—
−4K974536Photoderm HR SystemEsc Medical Systems, Ltd.1998—
−3K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.2000—
−2K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…Altus Medical, Inc.2002—
−1K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…Altus Medical, Inc.2002—
0 (this device)K031828Naturalase LP ND:Yag LaserFocus Medical, LLC2003—
+1K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC2004—
+2K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC2008—
+3K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC2011—
+4K123777Multilaser SystemUltralight Laser Technologies, LLC2013—
+5K233143PiXel8-RevealRohrer Aesthetics2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198810
199010
199140
199350
199480
199560
199680
199790
199860
199940
200090
2001100
2002120
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200810
201110
201310
202410
FIG. 1 — Lineage of K031828, 1992–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GEN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K023954Altus Medical Coolglide Laser Systems and Accessories
Summary page 1
…21 CFR 878.4810 Product Code: GEX Panel: 79 Predicate devices: Family of Altus CoolGlide Aesthetic Lasers (K023954, K022226, K014040, K003203), Laserscope Lyra System and Accessories (K003147, K020021, K010…
Altus Medical, Inc.2003—
*K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…
Summary page 1
…21 CFR 878.4810 Product Code: GEX Panel: 79 Predicate devices: Family of Altus CoolGlide Aesthetic Lasers (K023954, K022226, K014040, K003203), Laserscope Lyra System and Accessories (K003147, K020021, K010834, K990…
Altus Medical, Inc.2002—
*K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…
Summary page 1
…Product Code: GEX Panel: 79 Predicate devices: Family of Altus CoolGlide Aesthetic Lasers (K023954, K022226, K014040, K003203), Laserscope Lyra System and Accessories (K003147, K020021, K010834, K990903) and Cynosure Smartepil…
Altus Medical, Inc.2002—
*K003202Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II
Our reading of the summary gave K003203, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Family of Altus CoolGlide Aesthetic Lasers”.
Altus Medical2001—
*K003147Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration)
Summary page 1
…e devices: Family of Altus CoolGlide Aesthetic Lasers (K023954, K022226, K014040, K003203), Laserscope Lyra System and Accessories (K003147, K020021, K010834, K990903) and Cynosure Smartepil (K020197). Device description: The Focus Medical NaturaLas…
Laserscope2000—
*K020021Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)
Summary page 1
…: Family of Altus CoolGlide Aesthetic Lasers (K023954, K022226, K014040, K003203), Laserscope Lyra System and Accessories (K003147, K020021, K010834, K990903) and Cynosure Smartepil (K020197). Device description: The Focus Medical NaturaLase LP Lase…
Laserscope2002—
*K010834Lyra Series Surgical Laser System & Accessories
Summary page 1
…of Altus CoolGlide Aesthetic Lasers (K023954, K022226, K014040, K003203), Laserscope Lyra System and Accessories (K003147, K020021, K010834, K990903) and Cynosure Smartepil (K020197). Device description: The Focus Medical NaturaLase LP Laser in a lo…
Laserscope2001—
*K990903Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)
Summary page 1
…CoolGlide Aesthetic Lasers (K023954, K022226, K014040, K003203), Laserscope Lyra System and Accessories (K003147, K020021, K010834, K990903) and Cynosure Smartepil (K020197). Device description: The Focus Medical NaturaLase LP Laser in a long-pulse…
Laserscope1999—
*K020107Smartepil
Our reading of the summary gave K020197, FDA’s number for Modification to Datacaptor (Capsule Technologie). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cynosure Smartepil”.
Cynosure, Inc.2002—

Also cleared against K023954: 18 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044

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 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 2 of the 92 ancestors have a recall of any class.
  • Of its descendants, K041829 (Focus Medical, LLC, 2004) has gone furthest, with 4 descendants of its own.
  • 18 other devices also cite its predicate K023954.

How does its category compare?

All GEN devices

GEN Forceps, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEN

FDA has decided no GEN device since 2007.

Median 510(k) review, days · GEN

Too few GEN 510(k)s in any year since 2007 to give a median.

Recalls per year · GEN

3in 2024

2010: 12016: 12018: 12024: 3
2007high 3 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEN

30in 2025

2007: 262008: 152009: 222010: 212011: 162012: 182013: 242014: 232015: 272016: 192017: 342018: 162019: 182020: 62021: 202022: 182023: 252024: 202025: 30
2007high 34 (2017) · low 6 (2020)2025

MAUDE reports naming product code GEN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—026
20080—015
20090—022
20100—121
20110—016
20120—018
20130—024
20140—023
20150—027
20160—119
20170—034
20180—116
20190—018
20200—06
20210—020
20220—018
20230—025
20240—320
20250—030
20260—0—

What is it indicated for?

The Focus Medical NaturaLase LP Laser is indicated for: General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopicllaparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology. Dermatology/Plastic…

Read the full statement (648 words)

The Focus Medical NaturaLase LP Laser is indicated for:

General Surgical Applications:

Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopicllaparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology.

Dermatology/Plastic Surgery:

Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lake, leg and spider veins. In addition, the NaturaLase LP is 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 bluehlack tattoos) and plaques.

The NaturaLase LP Laser is also 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.

Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery.

The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles.

The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).

The NaturaLase LP iaser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The NaturaLase LP Laser is indicated for use on all skin types (Fitzpatrick [ - IV) including tanned skin.

EndoscopidLaparoscopic Surgery:

The NaturaLase LP Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied.

Gastroenterology:

Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestinal hemostasis including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, gastroiritestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyp:j, ulcer, colitis, and hemorrhoids.

General Surgery:

Incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids.

Gynecology:

Treatment of menorrhagia by photocoagulation of the endometrial lining of the: uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine ‘gyncwlogic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum.

Head and NecWOtorhinolaryngology (ENT):

Tissue incision, excision, ablation, and vessel hemostasis.

Hemostasis During Surgery:

Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.

Neurosurgery:

Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma.

Oculoplastics:

Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of bi'opsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents.

Orthopedics:

Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.

PuImonary Surgery:

Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.

Thoracic Surgery:

Cutting (incisiodexcision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporizatron, coagtflation, incisiodexcision, debulking, and ablation of lung tissue (thoracoscopy).

Urology:

All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitdia (including condyloma acuminata).

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K031828: Naturalase LP ND:Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031828

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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