(309 days)
Not Found. This is a De Novo classification request (DEN200028).
No
The document describes a light-based therapy device with filters and lightguides, controlled by software. There is no mention of AI, ML, image processing, or any data-driven algorithms for diagnosis, treatment planning, or device operation beyond basic parameter control.
Yes
The device is indicated for "Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD)", which addresses a medical condition, making it a therapeutic device.
No
The provided text explicitly states the device is Indicated for: "Improvement of signs of Dry Eye Disease (DED)...", indicating its therapeutic rather than diagnostic purpose. It is also "to be applied as an adjunct to other modalities," implying treatment, not detection or diagnosis.
No
The device description explicitly details hardware components such as a touch-screen control panel, power supply modules, cooling unit, switching module, handpiece, filters, and lightguides, in addition to the control software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a Universal IPL (Intense Pulsed Light) system that applies light energy to the skin on the face. It is used for the treatment of Dry Eye Disease due to Meibomian Gland Dysfunction.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is based on the interaction of light with the skin tissue.
Therefore, the device's intended use and mechanism of action do not align with the definition of an In Vitro Diagnostic. It is a therapeutic device that applies energy to the body.
N/A
Intended Use / Indications for Use
Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for: Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eve or lipid deficiency dry eve, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.
Product codes (comma separated list FDA assigned to the subject device)
QIU
Device Description
The Lumenis Stellar M22 System incorporates a touch-screen control panel, power supply modules, cooling unit, switching module and service panel, monitored and controlled by its control software. Selected parameter treatment options and corresponding relevant user information are displayed on the monitor screen. The subject device (ophthalmic use) uses the spectrum range of 400-1200 nm. The cut-off filters used in the Lumenis presets for Universal IPL pigmented lesions treatment with the Stellar M22 system are the 515, 560, 590, 615, 640 or 695nm filters. Each filter cuts off all light with a wavelength shorter than the number indicated on the filter. The filter is inserted inside the handpiece and is exchangeable.
Universal IPL skin treatments with the Stellar M22 may use one of the three lightguides, 8x15, 15x35 mm rectangles and 6 mm round, which are supplied as accessories. Lightguides are made of sapphire and couple the optical energy from the module to the treatment site.
The light pulse is activated by pressing one of the three pulse buttons (for right and left-handed users and different grips) located on the handpiece. Discharged light passes through an aperture containing a filter. into the LightGuide that is inserted in the bottom of the handpiece. The LightGuide delivers the emitted light energy to the treatment site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
malar region of the face, from tragus to tragus including the nose
Indicated Patient Age Range
22 years of age and older
Intended User / Care Setting
Prescription use in accordance with 21 CFR 801.109. (Implies healthcare professional use)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Study Type: multi-center, prospective, randomized, sham-controlled, superiority study.
- Population: Up to male or female subjects, 22-85 years of age, with signs and symptoms of DED caused by MGD.
- Main Inclusion Criteria: moderate to severe signs and symptoms of DED due to MGD:
- Tear break-up time (TBUT) ≤ 7 seconds
- Meibomian Gland Score (MGS) ≤ 12, for "glands in the lower eyelid .
- At least 5 non-atrophied meibomian glands in the lower eyelid
- Symptoms self-assessed using the OSDI questionnaire ≥ 23
- Fitzpatrick skin type I-IV
- Objectives:
- Primary: To determine effectiveness of combined Intense Pulsed Light Therapy and Meibomian Gland Expression (IPL+MGX) treatment in improving TBUT in eyes with moderate to severe signs and symptoms of DED due to MGD assessed at single follow-up visit 4 weeks after final treatment session (0) (4 days, 10 (4 days), TBUT evaluated using FUL-GLO fluorescein ophthalmic strips, 3 successive readings averaged.
- Secondary: To determine effectiveness of combined IPL+MGX treatment in improving symptoms of DED due to MGD as evaluated by OSDI questionnaire self-evaluation at single follow-up visit and by self-evaluation of Eye Dryness Score (EDS) at single followup using a visual analog scale (VAS), to determine effect on appearance of eyelids, as well as to determine safety of IPL treatment for this indication.
- Sample Size: Not specified exactly, but "1:1 ratio of Treatment to Control" is mentioned.
- Treatments: 4 sessions, each 2 weeks apart.
- Follow-up: 4 weeks after the final treatment.
- Key results:
- Primary effectiveness endpoint for improvement in TBUT was met. The study demonstrates a statistically significant difference in improvement in TBUT between device treatment group and control group (change in TBUT baseline to followup was 1.99±0.36 sec for IPL+MGX arm and 0.75±0.34 sec for control sham+MGX arm, between-group mean difference in TBUT of 1.24±0.50 sec).
- Secondary endpoint for between-group difference in PRO symptoms score was not met. The study did not demonstrate significantly greater benefit for the IPL device group with regard to self-reported dry eye symptoms (i.e., treatment group and control group showed similar overall mean improvement in dry eye symptom scores with no statistically significant difference in score improvement between groups, OSDI p=(b) (4) and EDS VAS p=(b) (4)).
- Supportive analyses for Symptoms of DED: Exploratory protocol-planned analysis of "OSDI responders" at follow-up (defined as OSDI (b) (4) interpreted as improvement to "mild or better" PRO symptoms score), shows clinical benefit for active IPL treatment group (b) (4) vs. the control group (b) (4).
- Supportive analyses for Signs of DED: Exploratory protocol-planned analysis of change in Meibomian Gland score (MGS) shows clinical benefit for IPL treatment group, improvement (b) (4) units in active arm vs. (b) (4) (4) units in control arm, a between-group difference of (b) (4) (4) units.
- Safety Outcomes: No Serious Adverse Events (SAEs), no UADEs. AE incidence 8.9% in IPL active treatment arm (2 ocular AEs, 2 skin AEs) compared to 20% incidence in the control arm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Clinical effectiveness measured by change in TBUT and OSDI scores.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found. This is a De Novo classification request (DEN200028).
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K193500, K170060, K142860, K060448, K020839, K994014, K950493
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.5201 Intense pulsed light device for managing dry eye.
(a)
Identification. An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate adverse events and improvement of dry eye signs and symptoms under anticipated conditions of use.
(2) Thermal safety assessment in a worst-case scenario must be performed to validate temperature safeguards.
(3) Performance testing must demonstrate electrical safety and electromagnetic compatibility (EMC) of the device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Physician and patient labeling must include:
(i) Device technical parameters;
(ii) A summary of the clinical performance testing conducted with the device;
(iii) A description of the intended treatment area location;
(iv) Warnings and instructions regarding the use of safety-protective eyewear for patient and device operator;
(v) A description of intense pulse light (IPL) radiation hazards and protection for patient and operator;
(vi) Instructions for use, including an explanation of all user interface components; and
(vii) Instructions on how to clean and maintain the device and its components.
0
DE NOVO CLASSIFICATION REQUEST FOR LUMENIS STELLAR M22
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Intense pulsed light (IPL) device for managing dry eye. An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.
NEW REGULATION NUMBER: 21 CFR 886.5201
CLASSIFICATION: Class II
PRODUCT CODE: QIU
BACKGROUND
DEVICE NAME: Lumenis Stellar M22
SUBMISSION NUMBER: DEN200028
DATE DE NOVO RECEIVED: April 4, 2020
- Lumenis Ltd. CONTACT: 6 Hakidma Street PO Box 240, Yokneam, ISR 2069204
INDICATIONS FOR USE
Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for: Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eve or lipid deficiency dry eve, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.
LIMITATIONS
The sale, distribution, and use of the Lumenis Stellar M22 is restricted to prescription use in accordance with 21 CFR 801.109.
1
IPL application combined with concurrent meibomian gland expression supports the proposed indication for use. Note that IPL treatment for this proposed indication is applied to the malar region of face from tragus to tragus (not to the eyes or eyelids).
During IPL treatment eyes are covered with adhesive eye patches and opaque goggles worn overlying them - these two types of eye protection completely occlude the eyes.
Serious safety consequences possible if eye protection is not worn per instructions for use and/or the IPL treatment is mis-used.
Known dermatologic adverse event risks largely consist of skin reactions including: flareup, irritation, infection, blistering, pruritis, dryness, temporary skin color changes, burns, prolonged edema or erythema, Herpes simplex virus reactivation, post inflammatory hyperpigmentation (PIH), contact dermatitis, and scarring.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The purpose of this submission is to modify the Indication for Use cleared under K193500 for dermatological use to include ophthalmic use. The device and IPL handpiece are identical in materials and manufacturing processes to those described in K 193500.
The Lumenis Stellar M22 System incorporates a touch-screen control panel, power supply modules, cooling unit, switching module and service panel, monitored and controlled by its control software. Selected parameter treatment options and corresponding relevant user information are displayed on the monitor screen. The subject device (ophthalmic use) uses the spectrum range of 400-1200 nm. The cut-off filters used in the Lumenis presets for Universal IPL pigmented lesions treatment with the Stellar M22 system are the 515, 560, 590, 615, 640 or 695nm filters. Each filter cuts off all light with a wavelength shorter than the number indicated on the filter. The filter is inserted inside the handpiece and is exchangeable.
Universal IPL skin treatments with the Stellar M22 may use one of the three lightguides, 8x15, 15x35 mm rectangles and 6 mm round, which are supplied as accessories. Lightguides are made of sapphire and couple the optical energy from the module to the treatment site.
2
Image /page/2/Figure/0 description: The image shows a medical device and diagrams related to IPL (Intense Pulsed Light) treatment. The device features a touch screen monitor, emergency shutoff knob, light/laser emission indicator, and connectors for modules. Diagrams illustrate the placement of eye patches, the position of the IPL light guide on the face, and the use of eye protection during the procedure. The IPL handpiece and light guide are also labeled.
| Device Technology
| Description: | DEN200028 |
|---|---|
| General Device Characteristics | |
| Universal Intense Pulsed | |
| Light (IPL) 400-1200 nm | IPL handpiece, comprised of: |
| • Xenon IPL flash lamp assembly and cooling | |
| components | |
| • ExpertFilters | |
| • SapphireCool LightGuides and thermo-Electric | |
| cooler | |
| • 3 pulse buttons |
3
The light pulse is activated by pressing one of the three pulse buttons (for right and left-handed users and different grips) located on the handpiece. Discharged light passes through an aperture containing a filter. into the LightGuide that is inserted in the bottom of the handpiece. The LightGuide delivers the emitted light energy to the treatment site.
Treatment time is brief, usually less than 10 minutes. The general treatment area includes the malar region, below the lower eyelids, from tragus (lower end of the ear) to tragus including the nose, and the peri-orbital area. At all times during IPL use, including during the test spot(s), the patient's eyes must be completely occluded.
Third-party Components and Accessories:
IPL third-party treatment accessories include:
For patients:
- coupling gel (transparent medical-grade, not contraindicated for use on facial skin) .
- adhesive eye patches for patients ((b) (4) ●
- goggles for patients ((b) (4)
For healthcare providers:
- protective eyewear for healthcare providers (b) (4) ●
A 'one-time welcome pack' will be provided to the user that will include specific third-party accessories.
SUMMARY OF NONCLINICAL/BENCH STUDIES
The non-clinical testing (applicable to the subject device) includes performance testing, Electrical Safety and Electromagnetic compatibility (ES/EMC), and biocompatibility testing as explained below.
ELECTROMAGNETIC CAPABILITY (EMC) AND ELECTRICAL SAFETY
The sponsor provided a declaration of conformity that the device complies with the following FDA recognized consensus standards (similar to the previous K193500 device):
- IEC 60601-1 ●
- IEC 60601-1-2 ●
BIOCOMPATIBILITY/MATERIALS
The subject device IPL handpiece contacts intact facial skin for a limited duration. According to the FDA guidance document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process," the biocompatibility endpoints for this type of patient contact are cytotoxicity, sensitization, and irritation or intracutaneous reactivity. While testing for these endpoints was not performed for the subject device, these endpoints were adequately addressed because the handpiece is identical in materials and manufacturing processes to that described in K193500. The labeling includes several warnings, including to avoid eye contact with coupling gel. If coupling gel eye contact
4
accidentally occurs, the labeling includes warnings to halt treatment, rinse eyes out for 15 minutes, and consult a physician if eye irritation or redness is observed.
SHELF LIFE/STERILITY
The Lumenis Stellar M22 is provided non-sterile. Cleaning and maintenance instructions of the device and accessories are included in the labeling.
SOFTWARE
The provided software information for the subject device was consistent with the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The M22 system software version 6.0 allows the M22 system to recognize the filter for the IPL spectral range and block all other applications and modules while filter is connected. Since the new risks are addressed by labeling, the device has a moderate Software Level of Concern (LOC). The risks and hazards associated with Stellar M22 system, including risks related to cybersecurity were handled as part of Risk Management Process of the Stellar M22 system. Appropriate mitigations were put in place to address patient safety risks and ensure proper device performance. The risks related to the identified threats were identified, analyzed, mitigated and verified within the Risk Management Process of the Stellar M22 system.
PERFORMANCE TESTING - BENCH
The subject device, including the IPL handpiece are identical in performance, materials and method of manufacture to the previously cleared family of IPL devices (e.g., K193500, K170060. K142860. K060448. K020839. K994014. K950493). The thermal hazard risk mitigations for the subject device leveraged the non-clinical (and clinical) testing that were performed for these similar devices, which had very similar treatment parameters. Specifically, prior non-clinical testing conducted that is applicable to the subject device included verification of temperature specifications for the treatment head of the delivery handpiece to prevent tissue damage due to overheating (e.g., K020839); verification of the device recommended treatment parameters by assessing light guide output spectrum and filter transmission characteristics measured by a spectrometer, and pulse duration and light energy distribution using fluence measurements by a calorimeter (e.g., K950493). Engineering design was validated through bench testing including design verification (e.g. output stability) and/or validation tests with testing results. New risks due to the new indication for use are addressed by labeline.
SUMMARY OF CLINICAL INFORMATION
The Sponsor performed a multi-center, prospective, randomized, sham-controlled, superiority study. A summary of the trial is provided, in brief, below:
Population: Up to male or female subjects, 22-85 years of age, with signs and symptoms of DED caused by MGD.
(b) (4) weeks Duration:
Main Inclusion Criteria: moderate to severe signs and symptoms of DED due to MGD:
5
- Tear break-up time (TBUT) ≤ 7 seconds
- Meibomian Gland Score (MGS) ≤ 12, for ""glands in the lower eyelid .
- At least 5 non-atrophied meibomian glands in the lower eyelid ●
- Symptoms self-assessed using the OSDI questionnaire ≥ 23 ●
- Fitzpatrick skin type I-IV (b) (4) ●
Objectives:
Primary: To determine effectiveness of combined Intense Pulsed Light Therapy and Meibomian Gland Expression (IPL+MGX) treatment in improving TBUT in eyes with moderate to severe signs and symptoms of DED due to MGD assessed at single follow-up visit 4 weeks after final treatment session (0) (4 days, 10 (4 days), TBUT evaluated using FUL-GLO fluorescein ophthalmic strips, 3 successive readings averaged.
Secondary: To determine effectiveness of combined IPL+MGX treatment in improving symptoms of DED due to MGD as evaluated by OSDI questionnaire self-evaluation at single follow-up visit and by self-evaluation of Eye Dryness Score (EDS) at single followup using a visual analog scale (VAS), to determine effect on appearance of eyelids, as well as to determine safety of IPL treatment for this indication.
Primary endpoint: The difference in change in TBUT from baseline (BL) to follow-up (FU), compared between the two study arms (TBUT change defined as FU minus BL).
Secondary endpoints:
- . The difference in the change in OSDI score from BL to FU, compared between subjects in 2 arms.
- The difference in the change in EDS VAS from BL to FU, compared between subjects in . 2 arms.
Sample Size:
Study arm, the change of TBUT from BL to FU (b) (4) Control arm, the change of TBUT from BL to FU(b) (4) Type I error of 0.05 (two-tailed test) Type II error of (b) (4)(power =(b) (4) 1:1 ratio of Treatment to Control
Number of sites: 3-4
Treatments: 4 sessions, each 2 weeks apart (6) davs. (6) (4) davs)
-
- Subjects report daily usage (frequency and dose) of eye drops, warm compresses and lid hygiene since the previous visit
-
- Pre-treatment biomicroscopy with slit lamp (observation of lid margins, eyelashes, conjunctiva)
-
- "Active IPL" treatment of malar region (tragus to tragus) or "Sham IPL" (control arm) on same facial area
-
- Meibomian gland expression (MGX) of the upper and lower eyelids in both eyes in each study group (IPL treatment group and Sham control group)
-
- Slit Lamp Biomicroscopy
-
- Self-assessment of pain/discomfort during IPL administration, using a VAS
6
-
- Self-assessment of pain/discomfort during MGX, using a VAS
Follow-up: 4 weeks after the final treatment (" days, + ""days)
Clinical Outcomes:
Primary effectiveness endpoint for improvement in TBUT was met. .
The study demonstrates a statistically significant difference in improvement in TBUT between device treatment group and control group (change in TBUT baseline to followup was 1.99±0.36 sec for IPL+MGX arm and 0.75±0.34 sec for control sham+MGX arm, between-group mean difference in TBUT of 1.24±0.50 sec).
Although a relatively small comparative benefit to TBUT improvement, support for "meaningful clinical benefit" is based on planned exploratory analyses and unplanned post-hoc analyses (see below).
Secondary endpoint for between-group difference in PRO symptoms score was not ● met.
The study did not demonstrate significantly greater benefit for the IPL device group with regard to self-reported dry eye symptoms (i.e., treatment group and control group showed similar overall mean improvement in dry eye symptom scores with no statistically significant difference in score improvement between groups, OSDI p=(b) (4) and EDS VAS p=(b) (4)).
- Supportive analyses for Symptoms of DED: ●
- Exploratory protocol-planned analysis of "OSDI responders" at follow-up o (defined as OSDI (b) (4) interpreted as improvement to "mild or better" PRO symptoms score), shows clinical benefit for active IPL treatment group (b) (4) vs. the control group (b) (4) | This outcome supports clinically meaningful benefit for a proportion of study population.
- Supportive analyses for Signs of DED: ●
- Exploratory protocol-planned analysis of change in Meibomian Gland score O (MGS) shows clinical benefit for IPL treatment group, improvement (b) (4) units in active arm vs. (b) (4) (4) units in control arm, a between-group difference of (b) (4) (4) units. This outcome supports clinically meaningful benefit for a subset of the study population.
- Post-hoc categorical analyses of TBUT improvement (i.e., change in TBUT о clinical category defined by change of two or more severity categories) shows clinical benefit for IPL treatment group (b) (4) improved, (b) (4)worsened and (b) (4) no change) compared to the control group ((b) (4) improved, (b) (4) worsened, (b) (4) no change). A larger proportion of patients in the IPL/MGX group improved by two or more TBUT severity levels compared to sham/MGX group, a between-group difference of (b) (4) In a similar analysis, when change was defined by one or more TBUT severity categories, a larger proportion of patients in the IPL/MGX group improved by one or more TBUT severity levels compared to the MGX only arm, a between group difference of (b) (4) 1
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- Post-hoc TBUT analyses of proportion of subjects with a TBUT consistent o with MGD (defined as TBUT (6) (4) seconds at baseline) who improved to non-MGD TBUT at follow-up (defined as TBUT (b) (4) seconds at follow-up) shows clinical benefit for IPL treatment group ((b) (4) improved to non-MGD TBUT) compared to the control group ((b) (4) improved to non-MGD TBUT).
NOTE: Regarding post-hoc analyses to support magnitude of TBUT primary endpoint as clinically meaningful benefit, categories were chosen as pre-defined in Tomlinson, et al., 2011 (i.e., Normal: ≥10 sec; Subclinical: